This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcting Early-onset Vitamin B12 Deficiency in Adult Patients Using Proton Pump Inhibitors (PPIs). The Primary Outcome is the Change in Serum Vitamin B12 Levels Over a 6-week

Launched by TANTA UNIVERSITY · May 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well two different ways of taking vitamin B12—by mouth (oral) or under the tongue (sublingual)—can help adults who have low levels of vitamin B12. Many people who take proton pump inhibitors (PPIs), which are medications that reduce stomach acid, may not absorb vitamin B12 as well. The trial will measure how much vitamin B12 levels in the blood improve after six weeks of treatment. It will also check if there are changes in other related health markers and how satisfied participants feel with their treatment.

To be eligible for this trial, participants need to be between 18 and 70 years old and have been using PPIs for 1 to 6 months. They should have a vitamin B12 level that is lower than normal but not too low, and they should not have taken vitamin B12 supplements before. However, individuals with certain health issues, like long-term gut diseases or severe liver or kidney problems, will not be eligible. If you join the trial, you will receive either oral or sublingual vitamin B12 for six weeks, and you'll be helping researchers understand the best way to treat vitamin B12 deficiency in people taking PPIs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-70.
• • PPI use for 1-6 months (new users).
• • Serum B12 between 150-300 pg/mL.
• • No known prior B12 supplementation.
• Exclusion Criteria:
• • History of long-term GI disease (e.g., Crohn's, celiac).
• • Previous gastrectomy/bariatric surgery.
• • Baseline anemia with hemoglobin \<9 g/dL.
• • Severe renal or liver failure.