Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial

University of West London50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Vitamin B12 Deficiency

Interventions

Inactive lozengeDIETARY_SUPPLEMENT

Manufactured to mimic 1mg methylcobalamin lozenge

MethylcobalaminDIETARY_SUPPLEMENT

Aimed at reducing plasma tHcy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

University of West London

London, Middlesex, United Kingdom

Outcomes

Primary Outcomes

Reduction of plasma total homocysteine of vegetarians

Time frame: 16 weeks per participant

Secondary Outcomes

Improvement in systolic and diastolic blood pressure

Time frame: 16 weeks per participant

Data from ClinicalTrials.gov

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