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

This study has been completed.
Sponsor:
Collaborators:
Institute of reproductive and Child Health
National Natural Science Foundation of China
Information provided by (Responsible Party):
Liu Jianmeng, Peking University
ClinicalTrials.gov Identifier:
NCT00755664
First received: September 18, 2008
Last updated: September 19, 2012
Last verified: September 2012

September 18, 2008
September 19, 2012
July 2007
September 2012   (final data collection date for primary outcome measure)
plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score [ Time Frame: 6,12 and 18 months ] [ Designated as safety issue: No ]
plasma homocysteine level, plasma folate acid and red blood cell folate acid [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755664 on ClinicalTrials.gov Archive Site
systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • folate receptor antibodies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • genetic variants [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hyperhomocysteinemia
Dietary Supplement: 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.
Other Name: vitamin supplement
  • Active Comparator: 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
    Intervention: Dietary Supplement: Low-dose complex B-vitamins
  • Placebo Comparator: Vitamin C
    Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.
    Intervention: Dietary Supplement: Low-dose complex B-vitamins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
60 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00755664
30572071
Yes
Liu Jianmeng, Peking University
Peking University
  • Institute of reproductive and Child Health
  • National Natural Science Foundation of China
Principal Investigator: Jianmeng Liu, Prof. Institute of reproductive and Child health, PUHSC
Peking University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP