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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Johns Hopkins University National Center for Research Resources (NCRR) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00807807 |
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.
Condition | Intervention | Phase |
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Heart Diseases |
Dietary Supplement: Folic Acid Drug: Placebo Folic Acid |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy 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 |
Enrollment: | 133 |
Study Start Date: | June 1996 |
Study Completion Date: | September 1996 |
Primary Completion Date: | September 1996 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Participants will receive placebo folic acid.
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Drug: Placebo Folic Acid
Placebo folic acid once a day for 6 weeks
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2: Experimental
Participants will receive 100 mcg of folic acid.
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Dietary Supplement: Folic Acid
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
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3: Experimental
Participants will receive 400 mcg of folic acid.
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Dietary Supplement: Folic Acid
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
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4: Experimental
Participants will receive 1000 mcg of folic acid.
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Dietary Supplement: Folic Acid
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
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5: Experimental
Participants will receive 2000 mcg of folic acid.
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Dietary Supplement: Folic Acid
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
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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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Johns Hopkins University School of Medicine ( Lawrence J. Appel, MD, MPH ) |
Study ID Numbers: | 617, U01 HL050981, M01-RR00052 |
Study First Received: | December 10, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00807807 History of Changes |
Health Authority: | United States: Federal Government |
Plasma Homocysteine Concentration Folate Homocysteine Supplements Folic Acid |
Folic Acid Vitamin B Complex Heart Diseases Hematinics |
Vitamins Trace Elements Micronutrients |
Folic Acid Vitamin B Complex Heart Diseases Hematinics Therapeutic Uses Growth Substances |
Vitamins Hematologic Agents Physiological Effects of Drugs Cardiovascular Diseases Micronutrients Pharmacologic Actions |