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

NCT01661309 | Completed DMC

• 1 other identifier: Methylcobalamin
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Hyperhomocysteinemia; Methylcobalamin; Cardiovascular disease; Plasma total homocysteine; Vegetarians

Outcome Measures

Primary Outcomes (1)

• Reduction of plasma total homocysteine of vegetarians

  16 weeks per participant

Secondary Outcomes (1)

• Improvement in systolic and diastolic blood pressure

  16 weeks per participant

Other Outcomes (1)

• Improvement in body mass index

  16 weeks per participant

Study Arms (2)

Inactive lozenge

PLACEBO COMPARATOR

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

Dietary Supplement: Inactive lozenge; Dietary Supplement: Methylcobalamin

Methylcobalamin

EXPERIMENTAL

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

Dietary Supplement: Inactive lozenge; Dietary Supplement: Methylcobalamin

Interventions

Inactive lozenge DIETARY_SUPPLEMENT

Manufactured to mimic 1mg methylcobalamin lozenge

Inactive lozenge; Methylcobalamin

Methylcobalamin DIETARY_SUPPLEMENT

Aimed at reducing plasma tHcy.

Also known as: Vitamin B12

Inactive lozenge; Methylcobalamin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a plasma tHcy \>10 micromol/L

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of West London: lead

Study Sites (1)

University of West London

London, Middlesex, TW8 9GA, United Kingdom

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Hyperhomocysteinemia; Cardiovascular Diseases

Interventions

mecobalamin; Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Amalia A Tsiami, PhD

  University of West London

  STUDY DIRECTOR

• David C Chappell, PhD

  University of West London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 9, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

GB (1)