Vitamin B12 Deficiency
Conditions
Keywords
Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians
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.
Interventions
DIETARY_SUPPLEMENTInactive lozenge
Manufactured to mimic 1mg methylcobalamin lozenge
DIETARY_SUPPLEMENTMethylcobalamin
Aimed at reducing plasma tHcy.
Sponsors
University of West London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of plasma total homocysteine of vegetarians | 16 weeks per participant |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in systolic and diastolic blood pressure | 16 weeks per participant |
Other
| Measure | Time frame |
|---|---|
| Improvement in body mass index | 16 weeks per participant |
Countries
United Kingdom
Outcome results
None listed