- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807807
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
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:
|
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
Investigators
- Principal Investigator: Lawrence J. Appel, MD, MPH, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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