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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Derek Obersby, University of West London
ClinicalTrials.gov Identifier:
NCT01661309
First received: August 6, 2012
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Vitamin B12 Deficiency
Dietary Supplement: Inactive lozenge
Dietary Supplement: Methylcobalamin

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

Resource links provided by NLM:


Further study details as provided by University of West London:

Primary Outcome Measures:
  • Reduction of plasma total homocysteine of vegetarians [ Time Frame: 16 weeks per participant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in systolic and diastolic blood pressure [ Time Frame: 16 weeks per participant ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Improvement in body mass index [ Time Frame: 16 weeks per participant ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vitamin B12

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661309

Locations
United Kingdom
University of West London
London, Middlesex, United Kingdom, TW8 9GA
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Derek Obersby, PhD Student, University of West London
ClinicalTrials.gov Identifier: NCT01661309     History of Changes
Other Study ID Numbers: Methylcobalamin
Study First Received: August 6, 2012
Last Updated: May 18, 2014
Health Authority: United Kingdom: Research Councils UK

Keywords provided by University of West London:
Hyperhomocysteinemia
Methylcobalamin
Cardiovascular disease
Plasma total homocysteine
Vegetarians

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Hyperhomocysteinemia
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014