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

Hyperhomocysteinemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755664
• Other study ID #: 30572071
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2008
• Last updated: June 4, 2015
• Start date: July 2007
• Est. completion date: September 2012

Study information

• Verified date: June 2015
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug AdministrationChina: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperhomocysteinemia

Intervention

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.

Locations

Country	Name	City	State
China	The maternal and Children health care hospital	Yuanshi county of Shijiazhuang	Hebei

Sponsors (3)

Lead Sponsor	Collaborator
Peking University	Institute of reproductive and Child Health, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	folate receptor antibodies		6 months	No
Other	genetic variants		6 months	No
Primary	plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score		6,12 and 18 months	No
Secondary	systolic blood pressure, diastolic blood pressure and hemoglobin		6 and 12 months	No