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

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ClinicalTrials.gov Identifier: NCT01661309
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Derek Obersby, University of West London

Tracking Information
First Submitted Date  ICMJE August 6, 2012
First Posted Date  ICMJE August 9, 2012
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
Reduction of plasma total homocysteine of vegetarians [ Time Frame: 16 weeks per participant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01661309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
Improvement in systolic and diastolic blood pressure [ Time Frame: 16 weeks per participant ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 6, 2012)
Improvement in body mass index [ Time Frame: 16 weeks per participant ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Vitamin B12 Deficiency
Intervention  ICMJE
  • Dietary Supplement: Inactive lozenge
    Manufactured to mimic 1mg methylcobalamin lozenge
  • Dietary Supplement: Methylcobalamin
    Aimed at reducing plasma tHcy.
    Other Name: Vitamin B12
Study Arms  ICMJE
  • Placebo Comparator: Inactive lozenge
    Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
    Interventions:
    • Dietary Supplement: Inactive lozenge
    • Dietary Supplement: Methylcobalamin
  • Experimental: Methylcobalamin
    Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
    Interventions:
    • Dietary Supplement: Inactive lozenge
    • Dietary Supplement: Methylcobalamin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2012)
60
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01661309
Other Study ID Numbers  ICMJE Methylcobalamin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Derek Obersby, University of West London
Study Sponsor  ICMJE University of West London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Amalia A Tsiami, PhD University of West London
Study Director: David C Chappell, PhD University of West London
PRS Account University of West London
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP