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

Phase 3

Completed

• Conditions: Heart Diseases
• Interventions: Drug: Placebo Folic Acid; Dietary Supplement: Folic Acid

• Registration Number: NCT00807807
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

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

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.

Study Timeline

• Study Start: 1996-06
• Primary Completion: 1996-09
• Study Completion: 1996-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo Folic Acid	Participants will receive placebo folic acid.
2	Folic Acid	Participants will receive 100 mcg of folic acid.
3	Folic Acid	Participants will receive 400 mcg of folic acid.
4	Folic Acid	Participants will receive 1000 mcg of folic acid.
5	Folic Acid	Participants will receive 2000 mcg of folic acid.

Primary Outcome Measures

Name	Time	Method
Plasma homocysteine levels	Measured at Week 6

Secondary Outcome Measures

Name	Time	Method
Serum folate levels	Measured at Week 6