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

Primary Purpose

Vitamin B12 Deficiency

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inactive lozenge
Methylcobalamin
Sponsored by
University of West London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin B12 Deficiency focused on measuring Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of West London

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Inactive lozenge

Methylcobalamin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction of plasma total homocysteine of vegetarians

Secondary Outcome Measures

Improvement in systolic and diastolic blood pressure

Full Information

First Posted
August 6, 2012
Last Updated
May 18, 2014
Sponsor
University of West London
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1. Study Identification

Unique Protocol Identification Number
NCT01661309
Brief Title
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency
Keywords
Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactive lozenge
Arm Type
Placebo Comparator
Arm Description
Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
Arm Title
Methylcobalamin
Arm Type
Experimental
Arm Description
Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inactive lozenge
Intervention Description
Manufactured to mimic 1mg methylcobalamin lozenge
Intervention Type
Dietary Supplement
Intervention Name(s)
Methylcobalamin
Other Intervention Name(s)
Vitamin B12
Intervention Description
Aimed at reducing plasma tHcy.
Primary Outcome Measure Information:
Title
Reduction of plasma total homocysteine of vegetarians
Time Frame
16 weeks per participant
Secondary Outcome Measure Information:
Title
Improvement in systolic and diastolic blood pressure
Time Frame
16 weeks per participant
Other Pre-specified Outcome Measures:
Title
Improvement in body mass index
Time Frame
16 weeks per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amalia A Tsiami, PhD
Organizational Affiliation
University of West London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David C Chappell, PhD
Organizational Affiliation
University of West London
Official's Role
Study Director
Facility Information:
Facility Name
University of West London
City
London
State/Province
Middlesex
ZIP/Postal Code
TW8 9GA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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