A Phase 3 interventional study of Low-dose complex B-vitamins in Hyperhomocysteinemia, sponsored by Peking University. Completed at 1 site in China. Open to participants aged 60 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Peking University · Phase 3, Interventional, and Prevention
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.
34 studies on the registry are indexed under Hyperhomocysteinemia; 4 are open to participants now.
This study's enrollment of 390 is above the median of 84 across 21 interventional studies indexed under Hyperhomocysteinemia.
Browse Hyperhomocysteinemia studies →Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: vitamin supplement
plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score
Time frame: 6,12 and 18 months
systolic blood pressure, diastolic blood pressure and hemoglobin
Time frame: 6 and 12 months
folate receptor antibodies
Time frame: 6 months
genetic variants
Time frame: 6 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin Supplement