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

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.

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 Overview

• Status: Completed
• Conditions: Vitamin B12 Deficiency
• Intervention / Treatment: Dietary supplement: Inactive lozenge; Dietary supplement: Methylcobalamin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • London, Middlesex, United Kingdom, TW8 9GA
      • University of West London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Improvement in body mass index	16 weeks per participant

Collaborators and Investigators

• Sponsor: University of West London
• Investigators: Study Director: Amalia A Tsiami, PhD, University of West London; Study Director: David C Chappell, PhD, University of West London

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 18, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Hyperhomocysteinemia; Methylcobalamin; Plasma total homocysteine; Vegetarians
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Metabolism, Inborn Errors; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Vitamin B Deficiency; Vitamin B 12 Deficiency; Hyperhomocysteinemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 12
• Other Study ID Numbers: Methylcobalamin