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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00807807
Acronym
FAST
Enrollment
133
Registered
2008-12-12
Start date
1996-06-30
Completion date
1996-09-30
Last updated
2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Plasma Homocysteine Concentration, Folate, Homocysteine, Supplements, Folic Acid

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.

Interventions

DIETARY_SUPPLEMENTFolic Acid

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

DRUGPlacebo Folic Acid

Placebo folic acid once a day for 6 weeks

Sponsors

Johns Hopkins University
CollaboratorOTHER
National Center for Research Resources (NCRR)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Plasma homocysteine levelsMeasured at Week 6

Secondary

MeasureTime frame
Serum folate levelsMeasured at Week 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026