Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)

Study Overview
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Brief Summary
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High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.

Detailed Description
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Elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. Folate is a type of B vitamin that occurs naturally in food. In nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. Folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. However, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. The purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults. This 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or B-vitamins. At a screening visit, participants will complete questionnaires on medical history, demographics, and diet. Also, height and weight will be measured, and a blood collection will occur. At a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. Participants will attend a final study visit at Week 6, at which time another blood collection will occur.

Official Title
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Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial

Conditions
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Heart Diseases

Intervention / Treatment
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* Dietary Supplement: Folic Acid
* Drug: Placebo Folic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Living in the Baltimore area Exclusion Criteria: Taking multivitamins or B-vitamins Unwilling to discontinue supplements for 8 weeks before study entry Use of intramuscular vitamin B12 Seizure disorder Pernicious anemia Long-term use of anti-folate drugs (e.g., methotrexate, sulfa-antibiotics)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Participants will receive placebo folic acid. | Drug: Placebo Folic Acid<br>* Placebo folic acid once a day for 6 weeks<br>|
| Experimental: 2<br>Participants will receive 100 mcg of folic acid. | Dietary Supplement: Folic Acid<br>* 100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks<br>* Other names: Folate;|
| Experimental: 3<br>Participants will receive 400 mcg of folic acid. | Dietary Supplement: Folic Acid<br>* 100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks<br>* Other names: Folate;|
| Experimental: 4<br>Participants will receive 1000 mcg of folic acid. | Dietary Supplement: Folic Acid<br>* 100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks<br>* Other names: Folate;|
| Experimental: 5<br>Participants will receive 2000 mcg of folic acid. | Dietary Supplement: Folic Acid<br>* 100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks<br>* Other names: Folate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma homocysteine levels |  | Measured at Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum folate levels |  | Measured at Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma Homocysteine Concentration, Folate, Homocysteine, Supplements, Folic Acid