Clinical trial NCT00807807: Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)
Official title: Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Diseases
Keywords: Plasma Homocysteine Concentration
Folate
Homocysteine
Supplements
Folic Acid
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
name: National Center for Research Resources (NCRR)
First posted: 2008-12-12
Enrollment: 133
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Plasma homocysteine levels
timeFrame: Measured at Week 6
Secondary outcomes:
measure: Serum folate levels
timeFrame: Measured at Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Lawrence J. Appel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: