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

NCT ID: NCT00755664

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-09-30

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.

Conditions

Hyperhomocysteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Low-dose complex B-vitamins

Intervention Type: DIETARY_SUPPLEMENT

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.

Vitamin C

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

Group Type: PLACEBO_COMPARATOR

Low-dose complex B-vitamins

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

vitamin supplement

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of reproductive and Child Health

UNKNOWN

Sponsor Role: collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Liu Jianmeng

Institute of reproductive and Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmeng Liu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute of reproductive and Child health, PUHSC

Locations

The maternal and Children health care hospital

Yuanshi County of Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

30572071

Identifier Type: -

Identifier Source: org_study_id