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