Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)
| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 2008 | ||||
| Last Updated Date | December 12, 2008 | ||||
| Start Date ICMJE | June 1996 | ||||
| Primary Completion Date | September 1996 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Plasma homocysteine levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00807807 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Serum folate levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study) | ||||
| Official Title ICMJE | Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Heart Diseases | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 133 | ||||
| Completion Date | September 1996 | ||||
| Primary Completion Date | September 1996 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00807807 | ||||
| Other Study ID Numbers ICMJE | 617, U01 HL050981, M01-RR00052 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lawrence J. Appel, MD, MPH, Johns Hopkins University School of Medicine | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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