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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-06-30

Study Completion Date

1996-09-30

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.

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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.

Conditions

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Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Intervention Type DIETARY_SUPPLEMENT

100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks

Interventions

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Folic Acid

100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo Folic Acid

Placebo folic acid once a day for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Folate

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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes