Clinical trial NCT00755664: Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhomocysteinemia
Keywords: homocysteine
folate acid,
vitamin B
random controlled trail
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Institute of reproductive and Child Health
name: National Natural Science Foundation of China
First posted: 2008-09-19
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score
timeFrame: 6,12 and 18 months
Secondary outcomes:
measure: systolic blood pressure, diastolic blood pressure and hemoglobin
timeFrame: 6 and 12 months
Other outcomes:
measure: folate receptor antibodies
timeFrame: 6 months
measure: genetic variants
timeFrame: 6 months
Locations:
city: Yuanshi county of Shijiazhuang
country: China
facility: The maternal and Children health care hospital
state: Hebei
Study officials:
affiliation: Institute of reproductive and Child health, PUHSC
name: Jianmeng Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: