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

Effects of Low-dose B-vitamins Supplementation on Plasma Homocysteine and Framingham Risk Score: Double Blind Randomized Controlled Trial in Healthy Chinese Elderly

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755664

Enrollment

390

Registered

2008-09-19

Start date

2007-07-31

Completion date

2012-09-30

Last updated

2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperhomocysteinemia

Keywords

homocysteine, folate acid,, vitamin B, random controlled trail

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.

Interventions

DIETARY_SUPPLEMENTLow-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 74 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
systolic blood pressure, diastolic blood pressure and hemoglobin	6 and 12 months

Other

Measure	Time frame
folate receptor antibodies	6 months
genetic variants	6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026