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| Name | Class |
|---|---|
| Institute of reproductive and Child Health | UNKNOWN |
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose complex B-vitamins | Active Comparator | 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 |
|
| Vitamin C | Placebo Comparator | Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose complex B-vitamins | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score | 6,12 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure, diastolic blood pressure and hemoglobin | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| folate receptor antibodies | 6 months | |
| genetic variants | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmeng Liu, Prof. | Institute of reproductive and Child health, PUHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The maternal and Children health care hospital | Yuanshi County of Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D020138 | Hyperhomocysteinemia |
| ID | Term |
|---|---|
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |