HIV (Human Immunodeficiency Virus) Infection notes and book

Epidemiology

• 40 million cases worldwide
• Incidence – 5m/year
• Deaths – 3m/year
• Prevalence of AIDS – >3million
• Most of these are women and children in Africa
• Types of virus
  • HIV-1 – the most prevalent type in Europe
  • HIV-2 causes a similar disease, but has a longer latency period
• UK incidence – 7500/year
• More common in heterosexual individuals than homosexual individuals since 1999.

Transmission

Sexual

75% sexual intercourse
5-7% oral sex
Evidence suggests that circumcision reduces the risk of infection by 60% – however there is some public belief that it provides immunity – it does not!
Risks (per sexual encounter):

• Anal sex – receiving partner – between 0.1 – 3%
• Anal sex – active partner – <0.1%
• Vaginal sex – female – 1 in 100,000
• Vaginal sex – male – 1 in 200,000
• Oral sex – less than 1 in 200,000
• Child birth – 15%
• Child birth + breast feeding – 25%

Blood products
IV drug use
Vertical transmission

Pathology

HIV is an RNA retrovirus. The virus is incorporated into a host cell, whereby, the viral enzyme transcriptase will begin transcription of the RNA to DNA. Then, the viral enzyme integrase will integrate the DNA into the host’s.

• The host cell will then produce viral polypeptides, which are cleaved into functional viral parts by the viral enzyme protease.
• Finally, complete virions are released by the host cell via budding

Infection of cells – These new virion can now infect new cells. They are capable of entering any cell that expresses the CD4 receptor. The virus will bind to CD4 receptors with the gp120 glycoprotein. Susceptible cells include:

• CD4+ T cells
• Macrophages
• Monocytes
• Neurons

CD4+ T cells will migrate to lymphoid tissue, and release millions of virons, ready to infect new cells.
As the infection progresses, destruction of CD4+ cells leads to reduced efficacy of the host immune system.  

Clinical features

HIV infection can be divided into stages:

Seroconversion – typically occurs 2-6 weeks after exposure. Is often asymptomatic, but in some individuals there may be a period of fever, malaise, myalgia, pharygnitis and maculopapular rash.
Asymptomatic infection – this can last for years

• 30% of patients will have a persistent generalized lymphadenopathy (PGL) – where there are lymph nodes 1cm in diameter at >2 extra-inguinal sites. This may last >3 months.

AIDS related complex (ARC) – this is a set of prodromal symptoms that precedes the onset of AIDS. It can include:

• Opportunistic infection (e.g. candidal infection, herpes etc)
• Night sweats
• High temp
• Diarrhoea

AIDS

• There is marked immunodeficiency
• Typically defined as a CD4 count <200 x 10⁶ / L

Diagnosis

P24 antigen – present in the blood in the first 3 months of infection. Usually levels drop by the time IgG and IgM are produced (3 months). Levels rise again as immunodeficiency develops.
HIV RNA – can also be detected using PCR techniques during the early stages of the infection

• Used to monitor progress and effectiveness of treatment (See below)

IgG and IgM – levels detectable after 3 months. Fall as immunodeficiency develops (try looking for P24).
OraQuick – is a method of detecting HIV antibodies in saliva. Fast and easy, but high false positives. 
HIV and TB – often co-exist, and can be a real problem.

• 30-50% of those with AIDS also have TB
• Mantoux test can be negative even in positive patients
• TB presentation is often atypical
• AFB (Acid-fast bacilli) Smear – may be negative, or have very few cells. Important to culture for sensitivities.
• All HIV positive patients should be regularly monitored for TB. Some recommend the use of isoniazid as prophylaxis in HIV positive patients.

Monitoring

The following should be measured every 3 months:

HIV RNA levels – strongly predict the progression to AIDS, regardless of the CD4 count!

• Patients can be ‘staged’ according to HIV RNA levels, e.g.:
• Those in the lowest quartile have an 8% of progressing to AIDS in 5 years, compared to 62% of those in the highest quartile.

CD4 count

• In the developing world, this test may be too expsenive. A total lymphocytes count may be adequate
• Total lymphocytes = 1400, then CD4 roughly =200
• This is accurate enough for predicting HIV progression

Viral load

Management

All newly diagnosed HIV positive patients should be tested for:

• TB
• Toxoplasma
• CMV
• Hepatitis B + C
• Syphilis

HAART – highly active anti-retroviral therapy

• In the developed world, this is the mainstay of treatment. There is not one specific recommended regimen – essentially all regimens are experimental combinations of anti-retroviral drugs
• It aims to reduce the rate of viral replication below detectable levels. This does not mean that replication is not occurring!
• HAART should be part of a holistic care approach.
• It is a combination of two Nuceloside analogue reverse transcriptase inhibitors (NRTI’s), PLUS
  • Either; a Protease Inhibitor (PI),
  • Or; a non-nucleoside reverse transcriptase inhibitor (NNRTI)

Principles of therapy

always use >3 drugs (don’t do double therapy)
Start treatment as early as possible – i.e. before CD4 count <200
When to start treatment?

• Any patient with AIDS
• Any patient with CD4 <200
  • Will probably be revised upwards soon (<275-300)

Any patient with CD4 200-350 with high viral load
Any patient with CD4 200-350, but CD4 falling fast

• Advise the patient that regimens are complex, and require strict adherence
• Monitor Viral load and CD4 count regularly.
• Ideally, viral load will be undetectable after 4 months of HAART
• If viral load is apparently erratic, consider poor adherence
• If firal load remains high despite treatment, change the regimen

NRTI’s – e.g. Zidovudine, Didanosine, Lamivudine, Emtricitabine, Tenofovir, Abacavir

• Side effect are not particularly pleasant, and include:
• Anaemia, leucopaenia, GI disturbance, rashes, myalgia, neuropathies, pancreatitis.
• CI’s: LFT disturbance, Hepatomegaly, lactic acidosis, breast feeding, anaemia. Monitor for liver problems and amylase.

Protease Inhibitors – e.g. Indinavir, Ritonavir, Saquinavir, Lopinavir

• Slow the viral spread, prolong the asymptomatic stage of the disease
• Metabolized y cytochrome P450 system – so can cause drug interactions
• Can cause metabolic syndrome (insulin resistance, hyperglycaemia, dyslipidaemia)
• Side effects: Taste disturbance, rash, pruritus (itch), hyperpigmentation, alopecia, parasthesia, myalgia, headache, dizziness, pancreatitis, anaemia, abnormal LFTs.

NNRTI’s e.g. Nevirapine, Efavirenz

• Again, involved with cytochrome P450
• Resistance occurs quickly
• Side effects
• Hepatitis, dizziness, avoid in pregnancy.

Prevention

PEP – post-exposure prophylaxis – anti HIV drugs can be taken as prophylaxis, if taken within 72 hours of exposure to HIV. This exposure could be in the form of sexual contact (including oral, vaginal, anal), or blood products contact.

Needlestick injuries

• Risk of HIV infection is <0.5%
  • Tests for HIV antibodies should be done at 3,6 and 8 months to check for seroconversion
•  Risk of Hep B infection is about 30%
• Make it bleed!
  • But do not suck, or put in bleech
• Get the details of the ‘donor’
• Report to occupational health ASAP
• Store blood samples from both parties
• Check risk
  • Related to the donor CD4 level and viral load
• Consider prophylaxis
  • Low risk – may not be needed
  • High risk – zidovudine – 250mg / 12h + lamivudine 150mg / 12h + indinavir 800mg / 8hr, all PO
  • Do a pregnancy test before starting on prophylaxis!
  • There have been about 100 cases worldwide, and 5 in the UK, of a healthcare working contracting HIV from a patient

Prevention of vertical transmission

15% risk of vertical transmission (higher in Africa)
Methods of prevention of vertical transmission:
All HIV positive mothers should              

• Take anti-retrovirals – nevirapine is recommended. If on another agent before pregnancy, switch to this once pregnant
• Consider Caesarian
• Usually elective caesarean at 38 weeks
• Vaginal delivery is a RF – if twins, the first twin is at greater risk of vertical transmission
• Abstain from breast feeding
• If all the above measures are adhered to, risk of transmission is about 2%.
• Have tests for genital infection at booking and at 28 weeks

Counseling for HIV testing

It is very important to remember that before you perform an HIV test you need to tell the patient about the implications of a positive result. You should:
Determine the level of risk (e.g. unprotected sex, number of partners, sex overseas)
Discuss the benefits of knowing if test is positive:

• Protect partner
• Reduce risk of vertical transmission
• Get treatment

Ask about major concerns e.g.:

• Telling partner / friends
• Job
• Mortgage (if can’t work)
• Confidentiality
• You don’t have an obligation to inform the partner as this would break confidentiality. Encourage patient to discuss these issues with partner – offer them to invite partner along to surgery if this would help.
• However – if the patient refuses to tell their partner, you should consult GUM specialists / MDU / MPS to discuss the cases. In some instances it may be acceptable to break confidentiality to inform those at risk.

Post-term counseling

• Again discuss effects on family, job, telling partner / friends
• Emphasize methods to reduce exposure.
• Long-term counseling – may involve making plans for death, e.g.
  • Making a will
  • Housing
  • Employment
  • Care of children
  • Involvement of GP, palliative care services, and HIV experts

Dietary supplement

:Bodybuilding supplement

A dietary supplement is either intended to provide nutrients in order to increase the quantity of their consumption, or to provide non-nutrient chemicals which are claimed to have a biologically beneficial effect.

Supplements as generally understood include vitamins, minerals, fiber, fatty acids, or amino acids, among other substances. U.S. authorities define dietary supplements as foods, while elsewhere they may be classified as drugs or other products.

There are more than 50,000 dietary supplements available. More than half of the U.S. adult population (53% – 55%) consume dietary supplements with most common ones being multivitamins.[1]

These products are not intended to prevent or treat any disease and in some circumstances are dangerous, according to the U.S. National Institutes of Health. For those who fail to consume a balanced diet, the agency says that certain supplements "may have value."[2] An exception is vitamin D, which is recommended in Nordic countries[3] due to weak sunlight.

Contents  [hide] 
1 Definition
2 Medical uses
3 Types
3.1 Vitamins
3.2 Dietary mineral
3.3 Amino acids and proteins
3.4 Essential fatty acids
3.5 Bodybuilding supplements
4 Industry
5 Controversy
6 Adverse effects
7 Physical and chemical properties
7.1 Adulteration in North America
8 Society and culture
8.1 Public health
8.2 Legal regulation
8.2.1 United States
8.2.2 Regulation in European Union
9 Research
10 See also
11 References
12 Further reading
13 External links
Definition
According to the United States Food and Drug Administration (FDA), dietary supplements are products which are not pharmaceutical drugs, food additives like spices or preservatives, or conventional food, and which also meet any of these criteria:[4]

The product is intended to supplement a person's diet, despite it not being usable as a meal replacement.[4]
The product is or contains a vitamin, dietary element, herb used for herbalism or botanical used as a medicinal plant, amino acid, any substance which contributes to other food eaten, or any concentrate, metabolite, ingredient, extract, or combination of these things.[4]
The product is labeled as a dietary supplement.[4]
In the United States, the FDA has different monitoring procedures for substances depending on whether they are presented as drugs, food additives, food, or dietary supplements.[4] Dietary supplements are eaten or taken by mouth, and are regulated in United States law as a type of food rather than a type of drug.[5] Like food and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not; and rather than requiring risk–benefit analysis to prove that the product can be sold like a drug, risk–benefit analysis is only used to petition that food or a dietary supplement is unsafe and should be removed from market.[4]

Medical uses
The intended use of dietary supplements is to ensure that a person gets enough essential nutrients.[6]

Dietary supplements should not be used to treat any disease or as preventive healthcare.[7] An exception to this recommendation is the appropriate use of vitamins.[7]

Supplements may create harm in several ways, including over-consumption, particularly of minerals and fat-soluble vitamins which can build up in the body.[8] The products may also cause harm related to their rapid absorption in a short period of time, quality issues such as contamination, or by adverse interactions with other foods and medications.[9]


There are many types of dietary supplements.

Vitamins
Main article: Vitamin
Vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[10] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals. Supplementation is important for the treatment of certain health problems but there is little evidence of benefit when used by those who are otherwise healthy.[11]

Dietary mineral
Main article: Mineral (nutrient)
Dietary elements, commonly called "dietary minerals" or "minerals", are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules.[citation needed]

Amino acids and proteins
Main articles: Amino acid and Protein (nutrient)
Amino acids are biologically important organic compounds composed of amine (-NH2) and carboxylic acid (-COOH) functional groups, along with a side-chain specific to each amino acid. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen, though other elements are found in the side-chains of certain amino acids.

Amino acids can be divided into three categories: essential amino acids, non-essential amino acids, and conditional amino acids. Essential amino acids cannot be made by the body, and must be supplied by food. Non-essential amino acids are made by the body from essential amino acids or in the normal breakdown of proteins. Conditional amino acids are usually not essential, except in times of illness, stress, or for someone challenged with a lifelong medical condition[citation needed].

Essential fatty acids
Main article: Essential fatty acids
Essential fatty acids, or EFAs, are fatty acids that humans and other animals must ingest because the body requires them for good health but cannot synthesize them.[12] The term "essential fatty acid" refers to fatty acids required for biological processes but does not include the fats that only act as fuel.

Bodybuilding supplements
Main article: Bodybuilding supplement
Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding and athletics. Bodybuilding supplements may be used to replace meals, enhance weight gain, promote weight loss or improve athletic performance. Among the most widely used are vitamin supplements, protein drinks, branched-chain amino acids (BCAA), glutamine, essential fatty acids, meal replacement products, creatine, weight loss products and testosterone boosters. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public their salience and frequency of use may differ when used specifically by bodybuilders.

Industry
In 2013, the global market of vitamins, minerals, and nutritional and herbal supplements (VMHS) was valued at $82 billion, with roughly 28 percent of that in the U.S., where sales increased by approximately $6 billion between 2007 and 2012.[13]

The vitamins and dietary supplements sector in the U.S. grew 4% in 2015, to reach US$27.2 billion. The U.S. market was highly competitive in 2015, as no single company accounted for more than a 5% share of value sales.[14]

Controversy
According to University of Helsinki food safety professor Marina Heinonen, more than 90% of dietary supplement health claims are incorrect.[15] In addition, ingredients listed have been found to be different from the contents. For example, Consumer Reports reported unsafe levels of arsenic, cadmium, lead and mercury in several of the protein powders that were tested.[16] Also, the CBC found that protein spiking (the addition of amino acid filler to manipulate analysis) was not uncommon,[17] however many of the companies involved challenged their claim.[18]

Adverse effects

Some products make extraordinary claims and contain active ingredients which may not have been proven effective.
Among general reasons for harmful effects of dietary supplements are: a) absorption in a short time; b) quality and contamination; and c) enhancing both positive and negative effects at the same time.[19] The number of incidents of liver damage from dietary supplements has tripled in a decade. Most of the products causing that effect were bodybuilding supplements. Some of the victims required liver transplants and some died. A third of the supplements involved contained unlisted steroids.[20] Mild to severe toxicity has occurred on many occasions due to dietary supplements, even when the active ingredients were essential nutrients such as vitamins, minerals or amino acids. This has been a result of adulteration of the product, excessive usage on the part of the consumer, or use by persons at risk for the development of adverse effects. In addition, a number of supplements contain psychoactive drugs, whether of natural or synthetic origin.[21][22]

Physical and chemical properties

Adulteration in North America
BMC Medicine published a study on herbal supplements in 2013. Most of the supplements studied were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[23][24]

An investigation by the New York Attorney General’s office reported in 2015 analyzed 78 bottles of herbal supplements from Walmart, Target, Walgreens and GNC stores in New York State using DNA barcoding, a method used to detect labeling fraud in the seafood industry. Only about 20% contained the ingredient on the label.[25][26]

Some supplements were contamined by rodent feces and urine.[27]

Only 0.3% of the 55,000 U.S. market dietary supplements have been studied regarding their common side effects.[20]

Society and culture
Public health
Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[28]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[29][30] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[31][32]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[33][34]:10

Legal regulation
United States
Main article: Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Regulation in European Union
The European Union's Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[35] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[36]

The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[37]

In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[38] referred to the European Court of Justice by the High Court in London.[39]

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[40] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[41]

Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[42]

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DIETARY SUPPLEMENTS: WHAT YOU NEED TO KNOW

The majority of adults in the United States take one or more dietary supplements either every day or occasionally. Today’s dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.

The Dietary Supplement Label

All products labeled as a dietary supplement carry a Supplement Facts panel that lists the contents, amount of active ingredients per serving, and other added ingredients (like fillers, binders, and flavorings). The manufacturer suggests the serving size, but you or your health care provider might decide that a different amount is more appropriate for you.

Effectiveness

If you don’t eat a nutritious variety of foods, some supplements might help you get adequate amounts of essential nutrients. However, supplements can’t take the place of the variety of foods that are important to a healthy diet. Good sources of information on eating well include the Dietary Guidelines for Americansexternal link disclaimer and MyPlateexternal link disclaimer.

Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, calcium and vitamin D are important for keeping bones strong and reducing bone loss; folic acid decreases the risk of certain birth defects; and omega-3 fatty acids from fish oils might help some people with heart disease. Other supplements need more study to determine their value. The U.S. Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed.

Safety and Risk

Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of unexpected side effects, especially when taking a new product.

Supplements are most likely to cause side effects or harm when people take them instead of prescribed medicines or when people take many supplements in combination. Some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person’s response to anesthesia. Dietary supplements can also interact with certain prescription drugs in ways that might cause problems. Here are just a few examples:

Vitamin K can reduce the ability of the blood thinner Coumadin® to prevent blood from clotting.
St. John’s wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs’ effectiveness.
Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.
Keep in mind that some ingredients found in dietary supplements are added to a growing number of foods, including breakfast cereals and beverages. As a result, you may be getting more of these ingredients than you think, and more might not be better. Taking more than you need is always more expensive and can also raise your risk of experiencing side effects. For example, getting too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.

Be cautious about taking dietary supplements if you are pregnant or nursing. Also, be careful about giving them (beyond a basic multivitamin/mineral product) to a child. Most dietary supplements have not been well tested for safety in pregnant women, nursing mothers, or children.

If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088 or completing a form onlineexternal link disclaimer. In addition, report your reaction to the dietary supplement company by using the contact information on the product label.

Quality

Dietary supplements are complex products. The FDA has established good manufacturing practices (GMPs) for dietary supplements to help ensure their identity, purity, strength, and composition. These GMPs are designed to prevent the inclusion of the wrong ingredient, the addition of too much or too little of an ingredient, the possibility of contamination, and the improper packaging and labeling of a product. The FDA periodically inspects facilities that manufacture dietary supplements.

In addition, several independent organizations offer quality testing and allow products that pass these tests to display their seals of approval. These seals of approval provide assurance that the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. These seals of approval do not guarantee that a product is safe or effective. Organizations that offer this quality testing include:



Don’t decide to take dietary supplements to treat a health condition that you have diagnosed yourself, without consulting a health care provider.

• Don’t take supplements in place of, or in combination with, prescribed medications without your health care provider’s approval.
• Check with your health care provider about the supplements you take if you are scheduled to have any type of surgical procedure.
• The term “natural” doesn’t always mean safe. A supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used. Certain herbs (for example, comfrey and kava) can harm the liver.
• Before taking a dietary supplement, ask yourself these questions:
• What are the potential health benefits of this dietary supplement product?
• What are its potential benefits for me?
• Does this product have any safety risks?
• What is the proper dose to take?
• How, when, and for how long should I take it?
• If you don’t know the answers to these questions, use the information sources listed in this brochure and talk to your health care providers.

Talk with Your Health Care Provider

Let your health care providers (including doctors, pharmacists, and dietitians) know which dietary supplements you’re taking so that you can discuss what’s best for your overall health. Your health care provider can help you determine which supplements, if any, might be valuable for you.

Keep a record of the supplements you take in one place, just as you should be doing for all of your medicines. Note the specific product name, the dose you take, how often you take it, and the reason why you use each one. You can also bring the products you use with you when you see your health care provider.

Federal Regulation of Dietary Supplements

Dietary supplements are products intended to supplement the diet. They are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both dietary supplements and medicines.

In general, the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require premarket review or approval by the FDA. While the supplement company is responsible for having evidence that their products are safe and the label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed.

Dietary supplement labels may carry certain types of health-related claims. Manufacturers are permitted to say, for example, that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (like immunity or heart health). Such a claim must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Manufacturers must follow certain good manufacturing practices to ensure the identity, purity, strength, and composition of their products. If the FDA finds a product to be unsafe or otherwise unfit for human consumption, it may take enforcement action to remove the product from the marketplace or work with the manufacturer to voluntarily recall the product.

Also, once a dietary supplement is on the market, the FDA monitors information on the product’s label and package insert to make sure that information about the supplement’s content is accurate and that any claims made for the product are truthful and not misleading. The Federal Trade Commission, which polices product advertising, also requires all information about a dietary supplement product to be truthful and not misleading.

The federal government can take legal action against companies and Web sites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

Federal Government Information Sources on Dietary Supplements

NATIONAL INSTITUTES OF HEALTH

The National Institutes of Health supports research on dietary supplements.

Office of Dietary Supplements
The Office of Dietary Supplements provides accurate and up-to-date scientific information about dietary supplements.
National Center for Complementary and Alternative Medicineexternal link disclaimer
National Center for Complementary and Alternative Medicine Clearinghouse: 1-888-644-6226
National Library of Medicineexternal link disclaimer
Medline Plusexternal link disclaimer
PubMedexternal link disclaimer
NIH Health Informationexternal link disclaimer
U.S. FOOD AND DRUG ADMINISTRATION

The Food and Drug Administrationexternal link disclaimer issues rules and regulations and provides oversight of dietary supplement labeling, marketing, and safety.

FEDERAL TRADE COMMISSION

The Federal Trade Commissionexternal link disclaimer polices health and safety claims made in advertising for dietary supplements.

U.S. DEPARTMENT OF AGRICULTURE

The U.S. Department of Agricultureexternal link disclaimer provides information on a variety of food and nutrition topicsexternal link disclaimer.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

The U.S. Department of Health and Human Services provides an encyclopedia of health topics, personal health tools, and health newsexternal link disclaimer.

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Thaanaa Serndha Koottam (Original Motion Picture Soundtrack) - EP

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It’s been seven years since Suriya had a festival release. After director AR Murugadoss’ 7aum Arivu, which hit screens on Diwali 2011, Thaanaa Serndha Koottam, which is all set for a Pongal release on 12 January, marks his second festival film in the last eight years. The team organized a pre-release event yesterday in Chennai with the entire cast and crew in attendance, although composer Anirudh Ravichander, who is busy working round the clock on re-recording, was conspicuous by his absence.

Suriya started his speech by wishing Rajinikanth, Kamal Haasan and Vishal who have entered the political arena in the last two months. “We all have been keenly watching Rajinikanth, Kamal Haasan and Vishal's decisions of late. They all have our support. I wish them a very good luck in their endeavors."

Thaanaa Serndha Koottam is produced by KE Gnanavel Raja’s Studio Green, who has earlier bankrolled Suriya’s Sillunu Oru Kadhal, Singam, Masss and lastly Singam 3 in 2017. Talking about his long-standing collaboration with Gnanavel, Suriya said, "I have done 35 films now. There's a lot of important filmmakers and fans who shaped my career. But, there is one person who played a significant role in this entire journey. It's my brother Gnanavel. He always cared about my well-being from the beginning. The choices and decisions he made and the directors he picked for me have played a crucial part in my career."

“Every day was a new experience for me in Thaanaa Serndha Koottam,” says Suriya

Suriya, who is teaming up with director Vignesh Shivan for the first time, lauded his working style and how he approaches everything with a positive mindset. “Vignesh Shivan is quite a positive person. The roles I have played always used to have a tinge of anger. But Vignesh changed it completely. He made me a silent and sensible person with this character. Every day was a new experience for me. There were times when I experienced difficulties in dialogue delivery and was stuck. I used to take time and deliver it properly. I believe there's a lot of freshness in the film. I have received encouraging feedback from everyone regarding my look in this film. Everyone said it's the Suriya they had been waiting to see on screen. The entire credits for my look go to Vignesh. It's entirely his stamp."

“Thaanaa Serndha Koottam is majorly different from my previous films,” says Suriya
Talking about having a festival release after a long time, Suriya said, "It's been seven years since I had a festival release. It's always an ecstatic feeling to entertain audiences during the festival time. Vignesh Shivan has captured the festive mood very well and has presented a film which everyone will enjoy. There will be no smoking/drinking disclaimer card in the movie. Even the censor board members appreciated Vignesh and said it's been a long time since they watched a film like that. Despite a lot of pressure, he has handled everything calmly and sensibly. I'm eagerly waiting to see the excitement of audiences in theaters. It's been a long time since I watched the FDFS (First Day First Show) of my films. I always used to watch my movies two days after the release because of the anxiety. I'm going to watch Thaanaa Serndha Koottam FDFS in theaters this time. This film made me remember my struggling days. There's a lot of positive things in the movie to take back home. Despite the fact that the film is set in the '80s period, Vignesh has done splendid work to ensure it connects with contemporary audiences. TSK is majorly different from my previous films."

“I’m sure you won’t find many shades of Special 26 in Thaanaa Serndha Koottam,” says director Vignesh Shivan

Director Vignesh Shivan reiterated once again that they had bought the remake rights of Special 26 legally before working on the project. “I wanted to write an original script. I desired to have every frame conceived by me. But due to time constraints, we had to opt for adaptation. We believe we have made an entertaining film for the Pongal festival,” he said.

Talking about how Suriya’s Kaakha Kaakha inspired him, Vignesh said, “Kaakha Kaakha was a movie which impressed a lot of aspiring filmmakers to enter the industry. I was carrying my school bag then. To think that I've directed Suriya sir now feels extremely good. I was always thinking to deliver an entertaining film. I believe we have made what we had set out to do."

Also starring Keerthy Suresh as the lead heroine, Thaanaa Serndha Koottam features Ramya Krishnan, Suresh Menon, Senthil, RJ Balaji and Sathyan in important roles. The film is slated to hit screens worldwide in Tamil and Telugu on January 12th.
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Nutritional Supplements

Nutritional Supplements 

Nutritional supplements include vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet.
Purpose
Nutritional supplements are used for many purposes. They can be added to the diet to boost overall health and energy; to provide immune system support and reduce the risks of illness and age-related conditions; to improve performance in athletic and mental activities; and to support the healing process during illness and disease. However, most of these products are treated as food and not regulated as drugs are.
Description
The Natural Nutritional Foods Association estimated that in 2003 nutritional supplements amounted to a $19.8 billion market in the United States. By category, vitamins provided $6.6 billion in sales, herbs $4.2 billion, meal supplements $2.5 billion, sports nutrition products $2.0 billion, minerals $1.8 billion, and specialty and other products totaling $2.7 billion. The nutritional supplement industry provides a huge array of products for consumer needs.
Vitamins
Vitamins are micronutrients, or substances that the body uses in small amounts, as compared to macronutrients, which are the proteins, fats, and carbohydrates that make up all food. Vitamins are present in food, but adequate quantities of vitamins may be reduced when food is overcooked, processed, or improperly stored. For instance, processing whole wheat grain into white flour reduces the contents of vitamins B and E, fiber, and minerals, including zinc and iron. The body requires vitamins to support its basic biochemical functions, and deficiencies over time can lead to illness and disease.
Vitamins are either water-soluble or fat-soluble. Water-soluble vitamins dissolve in water and pass through the body quickly, meaning that the body needs them on a regular basis. Water-soluble vitamins include the B-complex vitamins and vitamin C. Fat-soluble vitamins are stored in the body's fatty tissue, meaning that they remain in the body longer. Fat-soluble vitamins include vitamins A, D, E, and K.
The amount of vitamins needed by the body has been the subject of much research. The U.S. government has published recommended dietary allowances (RDAs) for each vitamin for the general population. These figures can be used as guidelines, but individuals may have different needs depending on gender, age, and health conditions.
Vitamins can be natural or synthetic. Natural vitamins are extracted from food sources, while synthetic vitamins are formulated in laboratory processes. The only vitamin for which there is a noted difference between the natural and synthetic forms is vitamin E. The natural form is labeled d-alpha-tocopherol while the synthetic form is named dl-alpha-tocopherol, with the extra "l" signifying laboratory production. Natural vitamin E has been shown to be slightly more absorbable by the body than the synthetic version, although for other vitamins no significant differences in absorption have been noted.
Minerals
Minerals are micronutrients and are essential for the proper functioning of the body. Cells in the body require minerals as part of their basic make-up and chemical balance, and minerals are present in all foods. Minerals can either be bulk minerals, used by the body in larger quantities, or trace minerals, used by the body in minute or trace amounts. Bulk minerals include sodium, potassium, calcium, magnesium, and phosphorus. Trace minerals include iron, zinc, selenium, iodine, chromium, copper, manganese, and others. Some studies have shown that the amount of minerals, particularly trace minerals, may be decreasing in foods due to mineral depletion of the soil caused by unsustainable farming practices and soil erosion. Supplemental minerals are available in chelated form, in which they are bonded to proteins in order to improve their absorption by the body.
Herbs
Herbal supplements are added to the diet for both nutritional and medicinal purposes. Herbs have been used for centuries in many traditional medicine systems, and as sources of phytochemicals, or substances found in plants that have notable effects in the body. Chinese medicine and Ayurvedic medicine from India, two of the world's oldest healing systems, use hundreds of herbal medications. Naturopathy and homeopathy, two other systems of natural healing, also rely on herbal preparations as their main sources of medication. The medicinal effects of herbs are getting scientific validation; about one-fourth of all pharmaceuticals have been derived directly from plant sources, including aspirin (found in willow bark), codeine (from poppy seeds), paclitaxel (Taxol), a patented drug for ovarian and breast cancer (from the Pacific Yew tree), and many others.
Herbs can supplement the diet to aid in overall health or to stimulate healing for specific conditions. For instance, ginseng is used as a general tonic to increase overall health and vitality, while echinacea is a popular herb used to stimulate the body's resistance to colds and infections. Herbs come in many forms. They can be purchased as capsules and tablets, as well as in tinctures, teas, syrups, and ointments.
Meal supplements
Meal supplements are used to replace or fortify meals. They may be designed for people with special needs, or for people with illnesses that may affect digestion capabilities and nutritional requirements. Meal supplements may contain specific blends of macronutrients, or proteins, carbohydrates, fats, and fiber. Some meal supplements consist of raw, unprocessed foods, or vegetarian or vegan options, or high protein and low fat composition. Meal supplements are available to support some popular diet programs. Meal supplements are often fortified with vitamins, minerals, herbs, and nutrient-dense foods.
Sports nutrition
Nutritional supplements may be designed to provide specialized support for athletes. Some of these consist of high-protein products, such as amino acid supplements, while other products contain nutrients that support metabolism, energy, and athletic performance and recovery. People engaging in intense athletic activity may have increased needs for water-soluble vitamins, antioxidants, and certain minerals, including chromium. Sports drinks contain blends of electrolytes (salts) that the body loses during exertion and sweating, as well as vitamins, minerals, and performance-supporting herbs.
Other nutritional supplements
Other nutritional supplements include nutrient-dense food products. Examples of these are brewer's yeast, spirulina (sea algea), bee pollen and royal jelly, fish oil and essential fatty acid supplements, colostrum (a specialty dairy product), psyllium seed husks (a source of fiber), wheat germ, wheatgrass, and medicinal mushrooms such as the shiitake and reishi varieties.
Specialty products may offer particular health benefits or are targeted for specific conditions. These products may consist of whole foods or may be isolated compounds from natural or synthetic sources. Examples include antioxidants, probiotics (supplements containing friendly bacteria for the digestive tract), digestive enzymes, shark cartilage, or other animal products, or chemical extracts such as the hormone DHEA (dehydroepiandrosterone) and coenzyme Q10, an antioxidant.
General guidelines
Considering average dietary needs and the prevalence of certain health conditions, some basic guidelines may provide the foundation for the effective use of nutritional supplements. First, a high quality, broad-spectrum multivitamin and mineral supplement, taken once per day, is recommended to provide a range of nutrients. This should contain the B-complex vitamins B6, B12, and folic acid, which may help prevent heart disease, and the minerals zinc and copper, which aid immunity. In addition to a multivitamin, antioxidants can be added to a supplementation routine. These include vitamin A (or beta-carotene), vitamin C, and vitamin E, and the mineral selenium. Antioxidants may have several positive effects on the body, such as slowing the aging process, reducing the risks of cancer and heart disease, and reducing the risks of illness and infection by supporting the immune system. Coenzyme Q10 is another antioxidant in wide usage, as studies have shown it may improve the health of the heart and reduce the effects of heart disease. Essential fatty acids, particularly omega-3, are also recommended as they are involved in many important processes in the body, including brain function. Calcium supplementation is recommended for the elderly and for women, to strengthen bones and prevent bone loss. Calcium supplements that are balanced with magnesium have a less constipating effect and are better absorbed.
After basic nutritional requirements are supported, supplements may be used to target specific needs and health conditions. For instance, athletes, men, women, children, the elderly, and vegetarians have differing needs for nutrients, and an informed use of supplements would take these differences into account. People suffering from health conditions and diseases may use specific supplements to target their condition and to support the body's healing capacity by providing optimal amounts of nutrients.
Recommended dosage
Dosages of nutritional supplements vary widely, depending on the product and individual needs. For vitamins and minerals, U.S. RDA's are essential guidelines. For other products, manufacturers' guidelines, consumer information sources such as nutritional books and magazines, and practitioners including nutritionists and naturopathic physicians may be consulted.
Precautions
Overall diet is an important first consideration for those considering nutritional supplementation. Healthy dietary habits can help optimize nutrition and the absorption of supplements, and nutritional supplements cannot substitute for a diet that is not nutritionally balanced in the first place. Supplements are best used moderately to supply any extra nutritional requirements. Sound diets contain a variety of wholesome foods. At least five servings per day of fruits and vegetables are recommended, as well as the inclusion of whole grains in the diet. Variety in the diet is important to provide a full range of vitamins and minerals. Overeating inhibits digestion and absorption of nutrients, while regular exercise contributes to sound nutrition, by improving metabolism and digestion. Drinking plenty of clean water prevents dehydration, improves digestion, and helps the body flush out impurities.
Generally, nutrients from food sources are more efficiently utilized by the body than isolated substances. For instance, fresh fruit and vegetable juice could be used to provide concentrated amounts of particular nutrients, such as vitamins A and C, to the diet. As another example, eating plenty of leafy green vegetables is a healthy option for those wishing to add calcium to the diet.
Vitamins and minerals are most easily digested with food. Fat-soluble vitamins should be taken with food that contains fat. Vitamins tend to work synergistically, meaning that they work together in order to be effective. For instance, vitamin E requires some of the B-complex vitamins and the minerals selenium and zinc for most effective absorption. Some minerals may not be absorbed or may inhibit each other when taken in improper ratios. Generally, a high quality, broad-spectrum vitamin and mineral supplement will be formulated to prevent unfavorable interactions.
Vitamin A can become toxic when taken in large amounts (over 100,000 International Units) on a daily basis over time, as can vitamin D. Substituting beta-carotene for vitamin A can alleviate this risk. Very large doses of minerals taken over long periods may have toxic effects in the body. Dosages far exceeding RDA's of vitamins are not recommended, nor are large doses of other supplements.
Consumers can make wise choices for nutritional supplementation by consulting professional nutritionists and naturopathic physicians. Nutritional supplements are best added into the diet slowly, starting with small dosages and working up to the manufacturers' recommended amounts over time. Also, some supplements, such as herbal medications that may stimulate processes in the body, are best taken intermittently, allowing the body occasional rest periods without the supplement. To avoid unfavorable interactions, nutritional supplements are best used moderately and individually, rather than taking handfuls of capsules and tablets for various needs and conditions at the same time. Finally, consumers should be wary of excessive or grandiose health claims made by manufacturers of nutritional supplements and rely on scientific information to validate these claims.
Side effects
Some nutritional supplements can cause upset stomach and allergic reactions, including rashes, flushing, nausea, sweating, and headaches.
Interactions
Herbal preparations and nutritional supplements may interact unfavorably with pharmaceutical drugs. For instance, some nutritional supplements recommended for nervous system function may not be recommended for those taking pharmaceutical antidepressants, such as taking 5-HTP, a nutritional supplement for the brain, or the herb St. John's Wort, with prescription antidepressants. Vitamin C should not be taken with aspirin, as it can irritate the stomach and limit absorption. Minerals should be taken in proper proportions to prevent unfavorable interactions; large amounts of zinc may deplete the body of the mineral copper, while too much calcium adversely affects the magnesium levels in the body. Balanced mineral supplements are recommended to alleviate these interactions.

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