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

Not Applicable

Completed

• Conditions: Vitamin B12 Deficiency
• Interventions: Dietary Supplement: Inactive lozenge; Dietary Supplement: Methylcobalamin

• Registration Number: NCT01661309
• Lead Sponsor: University of West London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-18
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive lozenge	Inactive lozenge	Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
Inactive lozenge	Methylcobalamin	Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
Methylcobalamin	Inactive lozenge	Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
Methylcobalamin	Methylcobalamin	Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction of plasma total homocysteine of vegetarians	16 weeks per participant

Secondary Outcome Measures

Name	Time	Method
Improvement in systolic and diastolic blood pressure	16 weeks per participant

Trial Locations

Locations (1)

University of West London; 🇬🇧 London, Middlesex, United Kingdom