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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

Page last updated: August 23, 2015

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