Vitamin B12 Deficiency Clinical Trial
Official title:
To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.
Verified date | May 2014 |
Source | University of West London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Councils UK |
Study type | Interventional |
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Having a plasma tHcy >10 micromol/L - Not suffering from conditions as described in exclusion criteria. - Vegetarian for at least one year. - Not participating in a weight reducing diet. - Not consuming regularly vitamin B12 supplements. - Give written consent to participate in clinical trial and be fluent in English language. Exclusion Criteria: - Having a plasma tHcy less or equal to 10 micromol/L. - Suffering from pernicious anemia or other vitamin B12 deficiency disease. - Undergone bowel surgery or suffer from gastrointestinal disease. - Pregnant, lactating or trying to conceive. - Smoker. - Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male). - Consume large amounts of caffeine (regular consumption of >4 cups of strong tea or coffee per day). - Use of medications known to influence nutritional status. - Have genetic metabolic disease. - Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer. - Have a known blood-borne infection (e.g. Hepatitis or HIV). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of West London | London | Middlesex |
Lead Sponsor | Collaborator |
---|---|
University of West London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Improvement in body mass index | 16 weeks per participant | No | |
Primary | Reduction of plasma total homocysteine of vegetarians | 16 weeks per participant | No | |
Secondary | Improvement in systolic and diastolic blood pressure | 16 weeks per participant | No |
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