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Completed

NCT Number: NCT00755664

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

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.

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Key information

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The maternal and Children health care hospital

Yuanshi County of Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose complex B-vitamins

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.

Other names: vitamin supplement

Primary outcomes

  1. plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score

    Time frame: 6,12 and 18 months

Secondary outcomes

  1. systolic blood pressure, diastolic blood pressure and hemoglobin

    Time frame: 6 and 12 months

Other outcomes

  1. folate receptor antibodies

    Time frame: 6 months

  2. genetic variants

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Institute of reproductive and Child Health
  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2008
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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