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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Vitamin B12 Deficiency

Intervention / Treatment
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* Dietary Supplement: Inactive lozenge
* Dietary Supplement: Methylcobalamin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Inactive lozenge<br>Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks | Dietary Supplement: Inactive lozenge<br>* Manufactured to mimic 1mg methylcobalamin lozenge<br>Dietary Supplement: Methylcobalamin<br>* Aimed at reducing plasma tHcy.<br>* Other names: Vitamin B12;|
| Experimental: Methylcobalamin<br>Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks. | Dietary Supplement: Inactive lozenge<br>* Manufactured to mimic 1mg methylcobalamin lozenge<br>Dietary Supplement: Methylcobalamin<br>* Aimed at reducing plasma tHcy.<br>* Other names: Vitamin B12;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of plasma total homocysteine of vegetarians |  | 16 weeks per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in systolic and diastolic blood pressure |  | 16 weeks per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians