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

Peking University

Status and phase: Completed; Phase 3

Conditions: Hyperhomocysteinemia

Treatments: Dietary Supplement: Low-dose complex B-vitamins

Study type: Interventional

Funder types: Other

Identifiers

NCT00755664

30572071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 60 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

390 participants in 2 patient groups, including a placebo group

Low-dose complex B-vitamins

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Low-dose complex B-vitamins

Vitamin C

Placebo Comparator group

Description:

Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.

Treatment:

Dietary Supplement: Low-dose complex B-vitamins