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New treatment option for Vitamin B12 Nutritional Deficiency
Official title Effect of Methylcobalamin and Cyanocobalamin Consumption on Vitamin B12 Nutritional Status
ClinicalTrials.gov ID: NCT05785585
What this study is testing
- What it's testing
- Vitamin B12 (B12, Cobalamin) is an essential micronutrient that humans are not capable of synthesizing and therefore must be ingested through food. In nature, B12 is basically only present in foods of animal origin.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Reus, Tarragona, Spain
- Reus, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reus, Tarragona, Spain; Reus, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.