Vitamin B12 DeficiencyNCT01661309
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
A study testing Inactive lozenge and Methylcobalamin in people with Vitamin B12 Deficiency, run by University of West London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- Inactive lozenge and Methylcobalamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of West London
London, Middlesex, TW8 9GA
About this study
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.
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.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- Inactive lozenge, Methylcobalamin
- Keywords
- Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians
- Medical subject headings
- Vitamin B 12 Deficiency, Hyperhomocysteinemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive lozengeDietary supplement
Manufactured to mimic 1mg methylcobalamin lozenge
MethylcobalaminDietary supplement
Also called Vitamin B12
Aimed at reducing plasma tHcy.
| Study group | Role | What they receive |
|---|---|---|
| Inactive lozenge | Placebo comparator | Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks Receives: Dietary Supplement: Inactive lozenge; Dietary Supplement: Methylcobalamin |
| Methylcobalamin | Experimental | Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks. Receives: Dietary Supplement: Inactive lozenge; Dietary Supplement: Methylcobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of plasma total homocysteine of vegetarians
Measured: 16 weeks per participant
Secondary outcomes (1)
Improvement in systolic and diastolic blood pressure
Measured: 16 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Obersby, University of West London
- Investigators
- Amalia A Tsiami, PhD, Study director, University of West LondonDavid C Chappell, PhD, Study director, University of West London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661309
- Sponsor's protocol ID
- Methylcobalamin
- Status last verified
- May 2014
- First submitted
- 6 Aug 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01661309
- Acronym / sponsor ID
- Methylcobalamin
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Hyperhomocysteinemia, Methylcobalamin, Cardiovascular disease, Plasma total homocysteine, Vegetarians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of West LondonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactive lozenge | Placebo comparator | Dietary Supplement: Inactive lozenge, Dietary Supplement: MethylcobalaminInactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks |
| Methylcobalamin | Experimental | Dietary Supplement: Inactive lozenge, Dietary Supplement: MethylcobalaminMethylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactive lozengeManufactured to mimic 1mg methylcobalamin lozenge | Dietary supplement | Inactive lozenge, Methylcobalamin |
| MethylcobalaminAlso: Vitamin B12Aimed at reducing plasma tHcy. | Dietary supplement | Inactive lozenge, Methylcobalamin |
Primary outcome
Reduction of plasma total homocysteine of vegetarians
Time frame: 16 weeks per participant
1 secondary outcome
Improvement in systolic and diastolic blood pressure
Time frame: 16 weeks per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalia A Tsiami, PhD study director
University of West London
David C Chappell, PhD study director
University of West London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactive lozenge and Methylcobalamin in people with Vitamin B12 Deficiency, run by University of West London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of plasma total homocysteine of vegetarians (time frame: 16 weeks per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.