NCT00755664

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 60 Years – 74 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Hyperhomocysteinemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low-dose complex B-vitamins	The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2008-09-19
• Last updated: 2015-06-08

Locations

1 site across 1 country: China