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

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Participants will receive placebo folic acid.
Placebo folic acid once a day for 6 weeks
Experimental: 2
Participants will receive 100 mcg of folic acid.
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
Other Names:
  • Folate
Experimental: 3
Participants will receive 400 mcg of folic acid.
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
Other Names:
  • Folate
Experimental: 4
Participants will receive 1000 mcg of folic acid.
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
Other Names:
  • Folate
Experimental: 5
Participants will receive 2000 mcg of folic acid.
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
Other Names:
  • Folate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma homocysteine levels
Time Frame: Measured at Week 6
Measured at Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum folate levels
Time Frame: Measured at Week 6
Measured at Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lawrence J. Appel, MD, MPH, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Actual)

September 1, 1996

Study Completion (Actual)

September 1, 1996

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (Estimate)

December 12, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

December 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 617
  • U01HL050981 (U.S. NIH Grant/Contract)
  • M01RR000052 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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