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

NCT ID: NCT01661309

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-05-31

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.

Conditions

Vitamin B12 Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Inactive lozenge

Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks

Group Type: PLACEBO_COMPARATOR

Inactive lozenge

Intervention Type: DIETARY_SUPPLEMENT

Manufactured to mimic 1mg methylcobalamin lozenge

Methylcobalamin

Intervention Type: DIETARY_SUPPLEMENT

Aimed at reducing plasma tHcy.

Methylcobalamin

Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.

Group Type: EXPERIMENTAL

Inactive lozenge

Intervention Type: DIETARY_SUPPLEMENT

Manufactured to mimic 1mg methylcobalamin lozenge

Methylcobalamin

Intervention Type: DIETARY_SUPPLEMENT

Aimed at reducing plasma tHcy.

Interventions

Inactive lozenge

Manufactured to mimic 1mg methylcobalamin lozenge

Intervention Type: DIETARY_SUPPLEMENT

Methylcobalamin

Aimed at reducing plasma tHcy.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Vitamin B12

Eligibility Criteria

Inclusion Criteria

• Having a plasma tHcy >10 micromol/L

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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of West London

OTHER

Sponsor Role: lead

Responsible Party

Derek Obersby

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amalia A Tsiami, PhD

Role: STUDY_DIRECTOR

University of West London

David C Chappell, PhD

Role: STUDY_DIRECTOR

University of West London

Locations

University of West London

London, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

Methylcobalamin

Identifier Type: -

Identifier Source: org_study_id