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

Vitamin B12 Deficiency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661309
• Other study ID #: Methylcobalamin
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: May 18, 2014
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of West London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

Dietary Supplement:
• Inactive lozenge
Manufactured to mimic 1mg methylcobalamin lozenge
• Methylcobalamin
Aimed at reducing plasma tHcy.

Locations

Country	Name	City	State
United Kingdom	University of West London	London	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
University of West London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in body mass index		16 weeks per participant	No
Primary	Reduction of plasma total homocysteine of vegetarians		16 weeks per participant	No
Secondary	Improvement in systolic and diastolic blood pressure		16 weeks per participant	No