Not Yet RecruitingPhase 3

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

23 participantsStarted 2026-12-30

Plain-language summary

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 treatment period. Secondary outcomes include changes in homocysteine levels, hemoglobin levels, and patient-reported satisfaction.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Serum Vitamin B12 Concentration

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT06966856

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

View on ClinicalTrials.gov More Hypovitaminosis b 12 trials