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.

Study Overview

• Status: Completed
• Conditions: Hyperhomocysteinemia
• Intervention / Treatment: Dietary supplement: Low-dose complex B-vitamins

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.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Yuanshi county of Shijiazhuang, Hebei, China, 050000
      • The maternal and Children health care hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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 Names: vitamin supplement
Placebo Comparator: Vitamin C; Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.	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 Names: vitamin supplement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
folate receptor antibodies	6 months
genetic variants	6 months

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: National Natural Science Foundation of China; Institute of reproductive and Child Health
• Investigators: Principal Investigator: Jianmeng Liu, Prof., Institute of reproductive and Child health, PUHSC

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 18, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: homocysteine; vitamin B; folate acid,; random controlled trail
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Metabolism, Inborn Errors; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Vitamin B Deficiency; Hyperhomocysteinemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: 30572071