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

This study is currently recruiting participants.
Verified August 2012 by University of West London
Sponsor:
Information provided by (Responsible Party):
Derek Obersby, University of West London
ClinicalTrials.gov Identifier:
NCT01661309
First received: August 6, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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 Affects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

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 ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661309

Contacts
Contact: Derek Obersby, BSc (Hons), PGCert Res. +44(0)1889881014 d.obersby025@btinternet.com

Locations
United Kingdom
University of West London Recruiting
London, Middlesex, United Kingdom, TW8 9GA
Contact: Amalia A Tsiami, PhD     +44(0)208209 ext 4422     amalia.tsiami@uwl.ac.uk    
Contact: David C Chappell, PhD     +44(0)208209 ext 4409     david.chappell@uwl.ac.uk    
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: August 6, 2012
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:
Malabsorption Syndromes
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
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 May 23, 2013