Clinical Trial: Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Low-dose B-vitamins Supplementation on Plasma Homocysteine and Framingham Risk Score: Double Blind Randomized Controlled Trial in Healthy Chinese Elderly

Brief Summary: The purpose of this study is to evaluate whether low dose complex B-vitamins (folic acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/B12 and high Hcy status.

Detailed Summary: Hyperhomocysteinemia has been well known as an independent risk factor for CVD. Numerous studies have demonstrated that certain kinds of vitamin B(folic acid,vitamin B6 and vitamin B12)can reduce Hcy level and may prevent CVD. However, the majority of those studies has been conducted always used high dose vitamin in patient or high risk population. There is thus absence of data that the effectiveness of low dose complex B-vitamins on the apparently Chinese elderly population with relative sub-nutritional status. Our study is just focus on the aforementioned aspect.
Sponsor: Peking University

Current Primary Outcome: plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score [ Time Frame: 6,12 and 18 months ]

Original Primary Outcome: plasma homocysteine level, plasma folate acid and red blood cell folate acid [ Time Frame: 18 months ]

Current Secondary Outcome: systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 6 and 12 months ]

Original Secondary Outcome: systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 18 months ]

Information By: Peking University

Dates:
Date Received: September 18, 2008
Date Started: July 2007
Date Completion:
Last Updated: June 4, 2015
Last Verified: June 2015