Effects of different forms of Vitamin B12 on nutritional status
Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status in Vegetarians With Marginal Vitamin B12 Deficiency. Randomized, Parallel, Placebo-Controlled, Triple-Blind Clinical Trial.
This study tests whether two types of Vitamin B12 can help vegetarians improve their Vitamin B12 levels and overall nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Eurecat Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Reus, Tarragona and 1 other locations) |
| Trial ID | NCT05785585 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of two forms of Vitamin B12, Methylcobalamin and Cyanocobalamin, on the nutritional status of individuals following a vegetarian diet. Participants will be assessed for their serum Vitamin B12 levels, and the study aims to determine which form is more effective in improving these levels. The research is particularly relevant for vegetarians who may be at risk of Vitamin B12 deficiency due to dietary restrictions. The study will involve a control group for comparison purposes.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 years or older who follow a vegetarian diet and have specific serum Vitamin B12 levels.
Not a fit: Patients with diagnosed gastrointestinal diseases or other medical conditions that affect Vitamin B12 absorption will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve Vitamin B12 supplementation strategies for vegetarians, enhancing their overall nutritional health.
How similar studies have performed: Previous studies have shown varying success with different forms of Vitamin B12 supplementation, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 18 years or older who follow a vegetarian diet. * Present serum vitamin B12 levels of 148-221 pmol/L and absence of symptoms associated with vitamin B12 deficiency. * Sign the informed consent. * Read, write and speak Catalan or Spanish. Exclusion Criteria: * Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease, celiac disease, ileal resection, Crohn's disease, constipation or atrophic gastritis), pancreatic diseases, kidney diseases, liver diseases, diabetes, cardiovascular diseases, pernicious anemia and cancer. * Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery). * Being on hemodialysis treatment. * Present values of body mass index ≤ 18.5 kg/m\^2 or ≥ 35 kg/m\^2. * Present anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women). * Having consumed or consume vitamin B12 or folate supplements for more than 2 months before inclusion in the study. * Have taken medications that affect the absorption and therapeutic response of vitamin B12 (such as methotrexate, metformin, proton pump inhibitors, H2 receptor antagonists, histamine, nitrous oxide, colchicine, neomycin, biguanides, cholestyramine, aminosalicylic acid, chloramphenicol and other bone marrow depressants) one month before inclusion in the study. * Be a smoker or ex-smoker in the last 6 months before inclusion in the study. * Take 2 or more Standard Beverage Units (SBU) daily or 17 SBU weekly for women, or take 4 or more SBU daily or 28 SBU weekly for men. * Present allergy or intolerance to the study products (microcrystalline cellulose, vitamin B12 or cobalt). * Being pregnant or intending to become pregnant. * Being in breastfeeding period. * Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
Where this trial is running
Reus, Tarragona and 1 other locations
- Fundació Eurecat — Reus, Tarragona, Spain (Recruiting)
- Eurecat — Reus, Spain (Recruiting)
Study contacts
- Principal investigator: Antoni Caimari, PhD — Fundació Eurecat
- Study coordinator: Antoni Caimari, PhD
- Email: antoni.caimari@eurecat.org
- Phone: 0034 977 300 431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.