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

Heart Diseases Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807807
• Other study ID #: 617
• Secondary ID: U01HL050981M01RR
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2008
• Last updated: July 28, 2016
• Start date: June 1996
• Est. completion date: September 1996

Study information

• Verified date: December 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 1996
• Est. primary completion date: September 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Dietary Supplement:
• Folic Acid
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks

Drug:
• Placebo Folic Acid
Placebo folic acid once a day for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	Johns Hopkins University, National Center for Research Resources (NCRR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma homocysteine levels		Measured at Week 6	No
Secondary	Serum folate levels		Measured at Week 6	No