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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):

August 6, 2012
August 9, 2012
May 20, 2014
March 2012
May 2014   (Final data collection date for primary outcome measure)
Reduction of plasma total homocysteine of vegetarians [ Time Frame: 16 weeks per participant ]
Same as current
Complete list of historical versions of study NCT01661309 on ClinicalTrials.gov Archive Site
Improvement in systolic and diastolic blood pressure [ Time Frame: 16 weeks per participant ]
Same as current
Improvement in body mass index [ Time Frame: 16 weeks per participant ]
Same as current
 
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
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.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Vitamin B12 Deficiency
  • Dietary Supplement: Inactive lozenge
    Manufactured to mimic 1mg methylcobalamin lozenge
  • Dietary Supplement: Methylcobalamin
    Aimed at reducing plasma tHcy.
    Other Name: Vitamin B12
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2014
May 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01661309
Methylcobalamin
Yes
Not Provided
Not Provided
Derek Obersby, University of West London
University of West London
Not Provided
Study Director: Amalia A Tsiami, PhD University of West London
Study Director: David C Chappell, PhD University of West London
University of West London
May 2014

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