Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
Information source: University of West London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B12 Deficiency
Intervention: Inactive lozenge (Dietary Supplement); Methylcobalamin (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: University of West London Official(s) and/or principal investigator(s):
Amalia A Tsiami, PhD, Study Director, Affiliation: University of West London
David C Chappell, PhD, Study Director, Affiliation: University of West London
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Reduction of plasma total homocysteine of vegetarians
Secondary outcome: Improvement in systolic and diastolic blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
University of West London, London, Middlesex TW8 9GA, United Kingdom
Additional Information
Starting date: March 2012
Last updated: May 18, 2014
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