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

Purpose

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.

Condition	Intervention	Phase
Hyperhomocysteinemia	Dietary Supplement: Low-dose complex B-vitamins	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effects of Low-dose B-vitamins Supplementation on Plasma Homocysteine and Framingham Risk Score: Double Blind Randomized Controlled Trial in Healthy Chinese Elderly

Resource links provided by NLM:

Genetics Home Reference related topics: argininosuccinic aciduria citrullinemia N-acetylglutamate synthase deficiency ornithine translocase deficiency

MedlinePlus related topics: B Vitamins Dietary Supplements Vitamin C

Drug Information available for: Ascorbic acid Folic acid Hydroquinone Sodium ascorbate Vitamin B Complex

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:

folate receptor antibodies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
genetic variants [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	390
Study Start Date:	July 2007
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: vitamin supplement

Arms

Assigned Interventions

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 Name: 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 Name: vitamin supplement

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.

Eligibility

Ages Eligible for Study:	60 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755664

Locations

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

Sponsors and Collaborators

Peking University

Institute of reproductive and Child Health

National Natural Science Foundation of China

Investigators

Principal Investigator:

Jianmeng Liu, Prof.

Institute of reproductive and Child health, PUHSC

More Information

No publications provided

Responsible Party:	Liu Jianmeng, Institute of reproductive and Child Health, Peking University
ClinicalTrials.gov Identifier:	NCT00755664 History of Changes
Other Study ID Numbers:	30572071
Study First Received:	September 18, 2008
Last Updated:	September 19, 2012
Health Authority:	China: Ethics Committee China: Food and Drug Administration China: National Natural Science Foundation

Keywords provided by Peking University:

homocysteine
folate acid,
vitamin B
random controlled trail

Additional relevant MeSH terms:

Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ascorbic Acid

Hydroquinone
Vitamins
Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Radiation-Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013