ClinicalTrials.gg
CompletedNCT01661309Updated May 20, 2014

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

An interventional study of Inactive lozenge and Methylcobalamin in Vitamin B12 Deficiency, sponsored by University of West London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-20.

Sponsored by University of West London · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vitamin B12 Deficiency

Keywords

  • Hyperhomocysteinemia
  • Methylcobalamin
  • Cardiovascular disease
  • Plasma total homocysteine
  • Vegetarians
03

In context

Vitamin B 12 Deficiency

73 studies on the registry are indexed under Vitamin B 12 Deficiency; 8 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 45 interventional studies indexed under Vitamin B 12 Deficiency.

Browse Vitamin B 12 Deficiency studies →

Lead sponsor

University of West London is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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 · Dietary Supplement: Methylcobalamin

  • Experimental
    Methylcobalamin

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

    Dietary Supplement: Inactive lozenge · Dietary Supplement: Methylcobalamin

Interventions

  • Dietary supplementInactive lozenge

    Manufactured to mimic 1mg methylcobalamin lozenge

  • Dietary supplementMethylcobalamin

    Aimed at reducing plasma tHcy.

    Also known as: Vitamin B12

06

What researchers measure

Primary outcomes

  1. Reduction of plasma total homocysteine of vegetarians

    Time frame: 16 weeks per participant

Secondary outcomes

  1. Improvement in systolic and diastolic blood pressure

    Time frame: 16 weeks per participant

Other outcomes

  1. Improvement in body mass index

    Time frame: 16 weeks per participant

07

Study locations

1 site
  • University of West London
    London, Middlesex TW8 9GA, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2012
First posted
Aug 9, 2012
Start
Mar 2012
Primary completionActual
May 2014
CompletionActual
May 2014
Last update
May 20, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01661309
Lead sponsor
University of West London
Responsible party
Derek Obersby (PhD Student, University of West London) — Principal investigator
First posted
Aug 9, 2012
Start date
Mar 2012
Primary completion
May 2014
Completion
May 2014
Last update
May 20, 2014

Study contacts

Amalia A Tsiami, PhD
study director · University of West London
David C Chappell, PhD
study director · University of West London

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Mecobalamin

Start the discussion