Effectiveness of Low Dose Complex B-Vitamins on Homocysteine Lowering Among Chinese Elderly--Randomized Control Trial (RCT) - Full Text View

Sponsors and Collaborators:	Peking University Institute of reproductive and Child Health National Natural Science Foundation of China
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00755664

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: complex vitamin B	Phase III

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

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Homocysteine Ascorbic acid 1,4-Benzenediol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Plasma Homocysteine Level Responses to Low Dose Complex B-Vitamins Supplementation Among the Elderly Aged 60-74 Yrs in Northern China--a Randomized, Placebo-Controlled, Double-Blind Trial

Further study details as provided by Peking University:

Primary Outcome Measures:

plasma homocysteine level, plasma folate acid and red blood cell folate acid [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

systolic blood pressure, diastolic blood pressure and hemoglobin [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator this arm includes eligible volunteers who received active comparator with 5 different codes but belongs to the same formulation	Dietary Supplement: complex vitamin B 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.
2: Placebo Comparator this arm includes eligible volunteers who received other 5 different codes intervention compared to arm 1. these 5 kinds have the same formulation with placebo	Dietary Supplement: complex vitamin B 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.

Arms

Assigned Interventions

1: Active Comparator

this arm includes eligible volunteers who received active comparator with 5 different codes but belongs to the same formulation

Dietary Supplement: complex vitamin B

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.

2: Placebo Comparator

this arm includes eligible volunteers who received other 5 different codes intervention compared to arm 1. these 5 kinds have the same formulation with placebo

Dietary Supplement: complex vitamin B

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.

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

Contacts

Contact: Quangang Qu, PhD.	86-01-82801142 ext 126	ququangang@gmail.com
Contact: Jianmeng Liu, Prof.	86-01-82801169	liujm@pku.edu.cn

Locations

China, Heibei
The maternal and Children health care hospital	Recruiting
Yuanshi county of Shijiazhuang, Heibei, China, 050000
Sub-Investigator: Quangang Qu, PhD.

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

Responsible Party:	Institute of reproductive and Child Health, PUHSC ( Liu jianmeng )
Study ID Numbers:	30572071
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00755664
Health Authority:	China: Ethics Committee; China: State Food and Drug Administration; China: National Natural Science Foundation

Keywords provided by Peking University:

homocysteine
folate acid,
vitamin B
random controlled trail

Study placed in the following topic categories:

Metabolic Diseases
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Hydroquinone
Hydroxocobalamin
Vitamin B 12
Vitamin B 6

Folic Acid
Metabolism, Inborn Errors
Inborn amino acid metabolism disorder
Genetic Diseases, Inborn
Pyridoxine
Metabolic disorder
Ascorbic Acid

ClinicalTrials.gov processed this record on January 13, 2009