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

Condition(s) targeted: Hyperhomocysteinemia

Intervention: complex vitamin B (Dietary Supplement)

Phase: Phase 3

Status: Recruiting

Sponsored by: Peking University

Official(s) and/or principal investigator(s):
Jianmeng Liu, Prof., Principal Investigator, Affiliation: Institute of reproductive and Child health, PUHSC

Overall contact:
Quangang Qu, PhD., Phone: 86-01-82801142, Ext: 126, Email: ququangang@gmail.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: plasma homocysteine level, plasma folate acid and red blood cell folate acid

Secondary outcome: systolic blood pressure, diastolic blood pressure and hemoglobin

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.

Minimum age: 60 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

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

Quangang Qu, PhD., Phone: 86-01-82801142, Ext: 126, Email: ququangang@gmail.com

The maternal and Children health care hospital, Yuanshi county of Shijiazhuang, Heibei 050000, China; Recruiting
Quangang Qu, PhD., Sub-Investigator

Starting date: January 2006
Last updated: September 18, 2008