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

Phase 3

Not yet recruiting

• Conditions: Hypovitaminosis b 12
• Interventions: Drug: Cyanocobalamin 1000 Mcg Oral Tablet; Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet; Other: Proton Pump Inhibitor therapy only

• Registration Number: NCT06966856
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-04
• Study First Submitted QC: 2025-05-04
• Last Update Submitted: 2025-05-04
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2026-12-30
• Primary Completion: 2028-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Vitamin B12 Group	Cyanocobalamin 1000 Mcg Oral Tablet	Participants in this arm will receive 1000 mcg oral cyanocobalamin daily for 6 weeks. The supplement will be administered as a swallowed tablet. Patients will continue their regular PPI therapy during the study period.
Sublingual Vitamin B12 Group	Cyanocobalamin 1000 Mcg Sublingual Tablet	Participants in this arm will receive 1000 mcg sublingual cyanocobalamin daily for 6 weeks. The supplement will be administered as a sublingual tablet placed under the tongue. Patients will continue their regular PPI therapy during the study period.
Control Group (PPI Only)	Proton Pump Inhibitor therapy only	Participants in this arm will continue their regular PPI therapy without receiving vitamin B12 supplementation. This arm serves as a control to evaluate natural changes in B12 levels without supplementation.

Primary Outcome Measures

Name	Time	Method
Change in Serum Vitamin B12 Concentration	Baseline and Week 6	Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin Level	Baseline and Week 6	To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.
Patient-Reported Satisfaction with Route of Supplementation	Week 6	At the end of the study, patients will be surveyed about their satisfaction and ease of use with the assigned supplementation route (oral or sublingual).
Change in Plasma Homocysteine Level	Baseline and Week 6	Plasma homocysteine levels will be measured at baseline and at 6 weeks to assess the functional improvement in vitamin B12 status.