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

Phase 3

Completed

• Conditions: Hyperhomocysteinemia
• Interventions: Dietary Supplement: Low-dose complex B-vitamins

• Registration Number: NCT00755664
• Lead Sponsor: Peking University

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 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• Male and female residents living in the field site for at least 12 months
• Aged 60-74 years

Exclusion Criteria

• History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes.
• Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months.
• Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine.
• Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose complex B-vitamins	Low-dose complex B-vitamins	Intervention group receives Low-dose complex B-vitamins every day. Low-dose complex B-vitamins contain 400µg of folic acid, 2mg of vitamin B6, 10µg of vitamin B12 and 50mg vitamin C. Daily supplementation lasts for 12 months
Vitamin C	Low-dose complex B-vitamins	Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.

Primary Outcome Measures

Name	Time	Method
plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score	6,12 and 18 months

Secondary Outcome Measures

Name	Time	Method
systolic blood pressure, diastolic blood pressure and hemoglobin	6 and 12 months

Trial Locations

Locations (1)

The maternal and Children health care hospital; 🇨🇳 Yuanshi county of Shijiazhuang, Hebei, China