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Vitamins

Clinical Trials  |  Add a link  |  Regulations  |  Discussion Board  |  Ask the Nurse | Last Update January 1st. 2009  |  About FDA.COM  | Media Kit

Vitamins are substances that your body needs to grow and develop normally. There are 13 vitamins your body needs. They are vitamins A, C, D, E, K and the B vitamins (thiamine, riboflavin, niacin, pantothenic acid, biotin, vitamin B-6, vitamin B-12 and folate). You can usually get all your vitamins from the foods you eat. Your body can also make vitamins D and K. People who eat a vegetarian diet may need to take a vitamin B12 supplement.

Each vitamin has specific jobs. If you have low levels of certain vitamins, you may develop a deficiency disease. For example, if you don't get enough vitamin D, you could develop rickets. Some vitamins may help prevent medical problems. Vitamin A prevents night blindness.

The best way to get enough vitamins is to eat a balanced diet with a variety of foods. In some cases, you may need to take a daily multivitamin for optimal health. However, high doses of some vitamins can make you sick.

On this page:

Vitamins are essential nutrients that contribute to a healthy life. Although most people get all the vitamins they need from the foods they eat, millions of people worldwide take supplemental vitamins as part of their health regimen.

Why Buy Vitamins?

There are many good reasons to consider taking vitamin supplements, such as over-the-counter multivitamins. According to the American Academy of Family Physicians (AAFP), a doctor may recommend that you take them:

  • for certain health problems
  • if you eat a vegetarian or vegan diet
  • if you are pregnant or breastfeeding

 

Vitamin Facts

Your body uses vitamins for a variety of biological processes, including growth, digestion, and nerve function. There are 13 vitamins that the body absolutely needs: vitamins A, C, D, E, K, and the B vitamins (thiamine, riboflavin, niacin, pantothenic acid, biotin, vitamin B-6, vitamin B-12 and folate). AAFP cites two categories of vitamins.

  • Water-soluble vitamins are easily absorbed by the body, which doesn't store large amounts. The kidneys remove those vitamins that are not needed.
  • Fat-soluble vitamins are absorbed into the body with the use of bile acids, which are fluids used to absorb fat. The body stores these for use as needed.

 

Practice Safety with Dietary Supplements

When it comes to purchasing dietary supplements, Vasilios Frankos, Ph.D., Director of FDA's Division of Dietary Supplement Programs, offers this advice: "Be savvy!"

Today's dietary supplements are not only vitamins and minerals. "They also include other less familiar substances such as herbals, botanicals, amino acids, and enzymes," Frankos says. "Check with your health care providers before combining or substituting them with other foods or medicines." Frankos adds, "Do not self-diagnose any health condition. Work with your health care providers to determine how best to achieve optimal health."

Consider the following tips before buying a dietary supplement:

  • Think twice about chasing the latest headline. Sound health advice is generally based on research over time, not a single study touted by the media. Be wary of results claiming a "quick fix" that departs from scientific research and established dietary guidance.
  • More may not be better. Some products can be harmful when consumed in high amounts, for a long time, or in combination with certain other substances.
  • Learn to spot false claims. If something sounds too good to be true, it probably is. Examples of false claims on product labels include:
    • Quick and effective "cure-all"
    • Can treat or cure disease
    • "Totally safe," "all natural," and has "definitely no side effects"

Other red flags include claims about limited availability, offers of "no-risk, money-back guarantees," and requirements for advance payment.

"Also ask yourself, "Is the product worth the money?'" Frankos advises. "Resist the pressure to buy a product or treatment on the spot. Some supplement products may be expensive or may not provide the benefit you expect. For example, excessive amounts of water-soluble vitamins, like vitamins C and B, are not used by the body and are eliminated in the urine."

Develop a Vitamin Strategy

It is important for consumers to have an overall strategy for how they will achieve adequate vitamin intakes. The 2005 Dietary Guidelines for Americans advises that nutrient needs be met primarily through consuming foods, with supplementation suggested for certain sensitive populations.

These guidelines, published by the Department of Health and Human Services and the U.S. Department of Agriculture (USDA), provide science-based advice to promote health and to reduce risk for chronic diseases through diet and physical activity. They form the basis for federal food, nutrition education, and information programs.

Barbara Schneeman, Ph.D., Director of FDA's Office of Nutritional Products, Labeling, and Dietary Supplements, says, "The Guidelines emphasize that supplements may be useful when they fill a specific identified nutrient gap that cannot or is not otherwise being met by the individual's intake of food." She adds, "An important point made in the guidelines is that nutrient supplements are not a substitute for a healthful diet."

 

Special Nutrient Needs

According to the Dietary Guidelines for Americans, many people consume more calories than they need without taking in recommended amounts of a number of nutrients. The Guidelines warn that there are numerous nutrients—including vitamins—for which low dietary intake may be a cause of concern. These nutrients are:

  • calcium, potassium, fiber, magnesium, and vitamins A (as carotenoids), C, and E (for adults)
  • calcium, potassium, fiber, magnesium, and vitamin E (for children and adolescents)
  • vitamin B-12, iron, folic acid, and vitamins E and D (for specific population groups).

Regarding the use of vitamin supplements, the Dietary guidelines include the following:

  • Consume a variety of nutrient-dense foods and beverages within and among the basic food groups. At the same time, choose foods that limit the intake of saturated and trans fats, cholesterol, added sugars, salt, and alcohol.
  • Meet recommended nutrient intakes within energy needs by adopting a balanced eating pattern, such as one of those recommended in the USDA Food Guide or the National Institute of Health's Dietary Approaches to Stop Hypertension (DASH) eating plan.
  • If you're over age 50, consume vitamin B-12 in its crystalline form, which is found in fortified foods or supplements.
  • If you're a woman of childbearing age who may become pregnant, eat foods high in heme-iron and/or consume iron-rich plant foods or iron-fortified foods with an iron-absorption enhancer, such as foods high in vitamin C.
  • If you're a woman of childbearing age who may become pregnant or is in the first trimester of pregnancy, consume adequate synthetic folic acid daily (from fortified foods or supplements) in addition to food forms of folate from a varied diet.
  • If you are an older adult, have dark skin, or are exposed to insufficient ultraviolet band radiation (such as sunlight), consume extra vitamin D from vitamin D-fortified foods and/or supplements.

 

How Vitamins are Regulated

Vitamin products are regulated by FDA as "Dietary Supplements." The law defines dietary supplements, in part, as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet.

Listed in the "dietary ingredient" category are not only vitamins, but minerals, botanicals products, amino acids, and substances such as enzymes, microbial probiotics, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms. The Dietary Supplement Health and Education Act of 1994 requires that all such products be labeled as dietary supplements.

In June 2007, FDA established dietary supplement "current Good Manufacturing Practice" (cGMP) regulations requiring that manufacturers evaluate their products through testing identity, purity, strength, and composition.

 

Risks of Overdoing It

As is the case with all dietary supplements, the decision to use supplemental vitamins should not be taken lightly, says Vasilios Frankos, Ph.D., Director of FDA's Division of Dietary Supplement Programs.

"Vitamins are not dangerous unless you get too much of them," he says. "More is not necessarily better with supplements, especially if you take fat-soluble vitamins.” For some vitamins and minerals, the National Academy of Sciences has established upper limits of intake (ULs) that it recommends not be exceeded during any given day. (For more information, visit www.nap.edu/catalog.php?record_id=6432#toc

Also, the AAFP lists the following side effects that are sometimes associated with taking too much of a vitamin.

 

Fat-soluble Vitamins

  • A (retinol, retinal, retinoic acid): Nausea, vomiting, headache, dizziness, blurred vision, clumsiness, birth defects, liver problems, possible risk of osteoporosis. You may be at greater risk of these effects if you drink high amounts of alcohol or you have liver problems, high cholesterol levels or don't get enough protein.
  • D (calciferol): Nausea, vomiting, poor appetite, constipation, weakness, weight loss, confusion, heart rhythm problems, deposits of calcium and phosphate in soft tissues.

If you take blood thinners, talk to your doctor before taking vitamin E or vitamin K pills.

 

Water-soluble Vitamins

  • B-3 (niacin): flushing, redness of the skin, upset stomach.
  • B-6 (pyridoxine, pyridoxal, and pyridoxamine): Nerve damage to the limbs, which may cause numbness, trouble walking, and pain.
  • C (ascorbic acid): Upset stomach, kidney stones, increased iron absorption.
  • Folic Acid (folate): High levels may, especially in older adults, hide signs of B-12 deficiency, a condition that can cause nerve damage.

Taking too much of a vitamin can also cause problems with some medical tests or interfere with how some drugs work.

 

Report Problems

If you believe that you are experiencing an adverse response to taking a vitamin or any dietary supplement, Frankos advises reporting it to your health care provider, as well as to the manufacturer whose name or phone number appears on the label. You can also report directly to FDA through its MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch

Starting December 22, 2007, any serious adverse events reported to a dietary supplement manufacturer must be reported to FDA within 15 days of the manufacturer receiving the adverse event report.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

 

For More Information

FDA 101: Dietary Supplements
http://www.fda.gov/consumer/updates/supplements080408.html

Dietary Supplements
www.cfsan.fda.gov/~dms/supplmnt.html

What Dietary Supplements Are You Taking?
www.cfsan.fda.gov/~dms/ds-take.html

Dietary Guidelines for Americans, 2005
www.health.gov/dietaryguidelines/dga2005/document/default.htm

National Institutes of Health Office of Dietary Supplements
http://dietary-supplements.info.nih.gov/

Dietary Reference Intakes: A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients
www.nap.edu/catalog.php?record_id=6432

 

Date Posted: November 19, 2007
Updated: November 21, 2007

 

 

Reference Links - Add a link

Clinical Trials - Add a clinical trial

 top
1
Not yet recruiting
Vitamin D Replacement After Kidney Transplant
Conditions:
Kidney Transplantation;   Vitamin D Deficiency 
Interventions:
Dietary Supplement: vitamin D3;   Dietary Supplement: vitamin D3 
 
 

 
2
Not yet recruiting
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
Conditions:
Kidney Transplantation;   Vitamin D Deficiency;   Renal Osteodystrophy 
Interventions:
Drug: Cholecalciferol;   Drug: Placebo 
 
 

 
3
Recruiting
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Condition:
Vitamin D Deficiency 
Interventions:
Drug: Prenatal Vitamin;   Drug: Cholecalciferol (Vitamin D3);   Drug: Cholecalciferol (Vitamin D3) 
 
 

 
4
Not yet recruiting
Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3
Condition:
Healthy 
Interventions:
Dietary Supplement: Vitamin D3 1000 IU;   Dietary Supplement: Placebo Tablet 
 
 

 
5
Not yet recruiting
Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis
Conditions:
Arthritis, Rheumatoid;   Vitamin D Deficiency 
Interventions:
Drug: Placebo in arm A and Vitamin D in arm B;   Drug: vitamin D 3 for arm A ,and matching placebo for arm B 
 
 

 
6
Recruiting
Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Condition:
Vitamin D Deficiency 
Interventions:
Drug: Vitamin D;   Drug: Vitamin D;   Drug: Vitamin D 
 
 

 
7
Recruiting
Safety of Vitamin D in the Elderly
Condition:
Vitamin D Deficiency 
Interventions:
Dietary Supplement: cholecalciferol (vitamin D);   Dietary Supplement: cholecalciferol (vitamin D) 
 
 

 
8
Recruiting
Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers
Condition:
Chronic Obstructive Pulmonary Disease (COPD) 
Interventions:
Dietary Supplement: Vitamin C, Vitamin E, Selenium;   Dietary Supplement: Placebo 
 
 

 
9
Recruiting
Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis
Conditions:
Cystic Fibrosis;   Vitamin D Deficiency 
Intervention:
Dietary Supplement: cholecalciferol 
 
 

 
10
Recruiting
Vitamin D Effects on Prostate Pathology
Condition:
Prostate Cancer 
Intervention:
Dietary Supplement: vitamin D3 (cholecalciferol) 
 
 

 
11
Recruiting
Impact of Vitamin D Status on Bones in Breastfed Infants
Condition:
Vitamin D Deficiency 
Intervention:
Dietary Supplement: Tri-Vi-Sol 
 
 

 
12
Recruiting
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
Condition:
Breast Neoplasms 
Interventions:
Drug: Vitamin D;   Drug: Calcium carbonate;   Drug: Calcium carbonate;   Drug: Vitamin D;   Other: Vitamin D 
 
 

 
13
Recruiting
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Condition:
Chemotherapy-Induced Neuropathy in Cancer Patients 
Interventions:
Dietary Supplement: Multivitamin, Vitamin B12, Vitamin B6.;   Dietary Supplement: Vitamin B12, Vitamin B6 
 
 

 
14
Recruiting
Impact of Maternal Supplementation With Dual Megadose of Vitamin A
Conditions:
Hypovitaminosis;   Vitamin A Deficiency 
Interventions:
Dietary Supplement: vitamin A;   Dietary Supplement: Placebo 
 
 

 
15
Recruiting
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
Conditions:
Vitamin D Insufficiency;   Vitamin D Deficiency 
Intervention:
Dietary Supplement: Cholecalciferol (vitamin D3) 
 
 

 
16
Recruiting
Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
Conditions:
Vitamin D Deficiency;   Pregnancy 
Intervention:
Drug: cholecalciferol (vitamin D3) 
 
 

 
17
Not yet recruiting
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Condition:
Scar 
Interventions:
Other: both oral placebo and topical cream placebo;   Other: oral placebo and topical tocotrienol;   Other: Oral vitamin E supplement and topical cream placebo;   Other: Oral vitamin E supplement and topical vitamin E cream;   Other: Oral placebo & topical cream placebo & vitamin-E cream;   Other: Oral vitamin-E supplement & cream placebo & vitamin-E cream 
 
 

 
18
Recruiting
Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan
Conditions:
Vitamin A Deficiency;   Mortality 
Intervention:
Dietary Supplement: Vitamin A 
 
 

 
19
Recruiting
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
Conditions:
Vitamin D Deficiency;   HIV Infections 
Intervention:
Drug: colecalciferol 
 
 

 
20
Not yet recruiting
Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.
Condition:
Burn 
Interventions:
Dietary Supplement: vitamin c;   Dietary Supplement: vitamin c;   Dietary Supplement: vitamin c 
 
 

 
21
Recruiting
The Absorption of Vitamin B12 Among Healthy Pregnant Women
Condition:
Pregnancy 
Intervention:
Dietary Supplement: B12 vitamin (Cyanocobalamin) 
 
 

 
22
Recruiting
Prevention of Vitamin D Deficiency
Condition:
Vitamin D Deficiency 
Intervention:
Drug: Vitamin D drops, 200 or 400 or 600 IU/day 
 
 

 
23
Recruiting
Vitamin D Levels in Children With IBD
Conditions:
Inflammatory Bowel Disease;   Crohn's Disease;   Ulcerative Colitis 
Interventions:
Dietary Supplement: ergocalciferol;   Dietary Supplement: Cholecalciferol 
 
 

 
24
Recruiting
Establishing the Vitamin D Requirements During Lactation
Condition:
Vitamin D Deficiency 
Intervention:
Drug: cholecalciferol (vitamin D3) 
 
 

 
25
Recruiting
The Interaction Between Calcium and Vitamin D Intake
Condition:
Osteoporosis 
Intervention:
Dietary Supplement: Calcium and vitamin D supplementation 
 
 

 
26
Recruiting
Vitamin D Repletion in Chronic Kidney Disease
Condition:
Chronic Kidney Disease 
Intervention:
Drug: Vitamin D3 
 
 

 
27
Recruiting
Vitamin D for Chemoprevention
Conditions:
Gastrointestinal Cancers;   Prostate Cancer;   Hypertension 
Interventions:
Dietary Supplement: Vitamin D;   Dietary Supplement: Placebo 
 
 

 
28
Not yet recruiting
Folic Acid and Vitamin B12 in Young Indian Children
Conditions:
Diarrhea;   Pneumonia 
Interventions:
Dietary Supplement: Folic Acid;   Dietary Supplement: Vitamin B12;   Dietary Supplement: Placebo folate and B12 
 
 

 
29
Not yet recruiting
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
Conditions:
Osteoporosis;   Cognitive Decline 
Interventions:
Dietary Supplement: Vitamin B12, folic acid, Vitamin D3;   Dietary Supplement: Placebo (Vitamin D3) - 600 IU per day 
 
 

 
30
Recruiting
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Conditions:
Vitamin D Deficiency;   Insulin Resistance;   Type 2 Diabetes Mellitus;   Cardiovascular Disease;   Hypertension 
Interventions:
Drug: Cholecalciferol and Calcium Carbonate;   Drug: Placebo and Calcium Carbonate 
 
 

 
31
Recruiting
Evaluation of Vitamin D Status in Children With Acute Burns
Conditions:
Burns;   Bone Demineralization 
Interventions:
Dietary Supplement: Vitamin D2;   Dietary Supplement: Vitamin D3 
 
 

 
32
Recruiting
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Conditions:
Polycystic Ovarian Syndrome;   Vitamin D Deficiency 
Interventions:
Dietary Supplement: Vitamin D2 (Ergocalciferol);   Drug: Medroxyprogesterone (Provera);   Dietary Supplement: Vitamin D3 (Cholecalciferol);   Dietary Supplement: Elemental Calcium 
 
 

 
33
Recruiting
Evaluation of Vitamin D Requirements During Pregnancy
Condition:
Vitamin D Deficiency 
Intervention:
Drug: cholecalciferol (vitamin D3) 
 
 

 
34
Recruiting
Vitamin D and Blood Pressure
Condition:
Hypertension 
Intervention:
Drug: Vitamin D 
 
 

 
35
Recruiting
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Condition:
Vitamin B12 Malabsorption 
Intervention:
Drug: Vitamin B12 (drug) 
 
 

 
36
Recruiting
Vitamin D Supplementation in Younger Women
Condition:
Hypovitaminosis D 
Interventions:
Drug: vitamin D3;   Drug: vitamin D3 
 
 

 
37
Recruiting
Effectiveness of Low Dose Complex B-Vitamins on Homocysteine Lowering Among Chinese Elderly--Randomized Control Trial (RCT)
Condition:
Hyperhomocysteinemia 
Intervention:
Dietary Supplement: complex vitamin B 
 
 

 
 
39
Recruiting
Trial of the Impact of Vitamin A on Maternal Mortality
Conditions:
Vitamin A Deficiency;   Maternal Mortality;   Maternal Morbidity 
Intervention:
Dietary Supplement: Vitamin A 
 
 

 
40
Recruiting
L-Arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)
Condition:
Smear Positive Pulmonary Tuberculosis 
Interventions:
Drug: L-arginine;   Drug: Vitamin D;   Drug: Placebo L-arginine;   Drug: Placebo Vitamin D 
 
 

 
41
Recruiting
Vitamin D in Active Tuberculosis (TB) Study
Condition:
Tuberculosis 
Interventions:
Drug: Vitamin D3;   Drug: Placebo 
 
 

 
42
Not yet recruiting
Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease
Condition:
Crohn's Disease 
Interventions:
Drug: Colecalciferol D3 (Vigantol Oil);   Drug: Medium chain triglycerides 
 
 

 
43
Recruiting
Effect af Vitamin D Treatment in Primary Hyperparathyroidism
Conditions:
Vitamin D Deficiency;   Primary Hyperparathyroidism;   Hypercalcemia 
Intervention:
Drug: Cholecalciferol 
 
 

 
44
Recruiting
Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
Condition:
HIV Infections 
Interventions:
Dietary Supplement: Vitamin D supplement;   Other: Placebo 
 
 

 
45
Recruiting
Low Dose Supplementation to Improve Anticoagulation Control With Oral Vitamin K as an Adjuvant to Warfarin Therapy
Condition:
Coagulation 
Interventions:
Dietary Supplement: Vitamin K1 (Phytonadione);   Dietary Supplement: Placebo 
 
 

 
46
Not yet recruiting
Vitamin D3 in Systemic Lupus Erythematosus
Condition:
Systemic Lupus Erythematosus 
Interventions:
Dietary Supplement: Vitamin D3;   Dietary Supplement: Vitamin D3 placebo 
 
 

 
47
Not yet recruiting
Vitamin A Supplementation for Modulation of Mycobacterium Tuberculosis Immune Responses in Latent Tuberculosis.
Condition:
Latent Tuberculosis Infection 
Interventions:
Drug: Vitamin A;   Drug: Vitamin A placebo 
 
 

 
48
Recruiting
Vitamin D for Painful Nocturnal Leg Cramps
Condition:
Cramps 
Interventions:
Drug: vitamin d;   Drug: placebo 
 
 

 
49
Recruiting
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Conditions:
Glucose Intolerance;   Type 2 Diabetes Mellitus;   Metabolic Syndrome 
Interventions:
Drug: Vitamin D3 2,000 IU orally once daily;   Drug: Calcium Carbonate 400 mg orally twice daily;   Drug: Vitamin D3-Placebo;   Drug: Calcium-Placebo 
 
 

 
50
Not yet recruiting
Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants
Condition:
Vitamin D Deficiency 
Intervention:
Drug: Vitamin D3