Effectiveness of Low Dose Complex B-Vitamins on Homocysteine Lowering Among Chinese Elderly--Randomized Control Trial (RCT)

Official Title: “Plasma Homocysteine Level Responses to Low Dose Complex B-Vitamins Supplementation Among the Elderly Aged 60-74 Yrs in Northern China--a Randomized, Placebo-Controlled, Double-Blind Trial”

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.

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: complex vitamin B
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • this arm includes eligible volunteers who received active comparator with 5 different codes but belongs to the same formulation
• Placebo Comparator: 2
  • this arm includes eligible volunteers who received other 5 different codes intervention compared to arm 1. these 5 kinds have the same formulation with placebo

Primary Measures

• plasma homocysteine level, plasma folate acid and red blood cell folate acid
  • Time Frame: 18 months
    Safety Issue?: No

Secondary Measures

• systolic blood pressure, diastolic blood pressure and hemoglobin
  • Time Frame: 18 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Peking University Other

Overall Clinical Trial Officials and Contacts

Jianmeng Liu, Prof. Principal Investigator Institute of reproductive and Child health, PUHSC  

Overall Contact: Quangang Qu, PhD. 86-01-82801142 ququangang@gmail.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00755664

Study ID Number: 30572071

ClinicalTrials.gov Identifier: NCT00755664

Health Authority: China: Ethics Committee