Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial (NCT01661309) | Clinical Trial Compass
CompletedNot Applicable
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
United Kingdom50 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of plasma total homocysteine of vegetarians