Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status

Launched by FUNDACIÓ EURECAT · Mar 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different forms of vitamin B12 supplements, Methylcobalamin and Cyanocobalamin, on people who follow a vegetarian diet and have low levels of vitamin B12. Vitamin B12 is crucial for our bodies, and not getting enough can lead to health issues like anemia and other serious conditions. The researchers want to find out if Methylcobalamin, which is a natural and active form of vitamin B12, is more effective than the synthetic form, Cyanocobalamin, in improving vitamin B12 levels and related health markers.

To be eligible for this study, participants should be at least 18 years old, follow a vegetarian diet, and have specific low levels of vitamin B12 without showing any symptoms of deficiency. Throughout the trial, participants will attend several visits over about three months to monitor their health and how well the supplements work. It's important to note that individuals with certain medical conditions or those taking specific medications may not qualify to ensure everyone's safety and the accuracy of the results.

Gender

ALL

Eligibility 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.