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

Tanta University

Status and phase: Begins enrollment in a year or more; Phase 3

Conditions: Hypovitaminosis b 12

Treatments: Other: Proton Pump Inhibitor therapy only; Drug: Cyanocobalamin 1000 Mcg Oral Tablet; Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06966856

ORSUB12

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 3 patient groups

Oral Vitamin B12 Group

Experimental group

Description:

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.

Treatment:

Drug: Cyanocobalamin 1000 Mcg Oral Tablet

Sublingual Vitamin B12 Group

Experimental group

Description:

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.

Treatment:

Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet

Control Group (PPI Only)

Active Comparator group

Description:

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.

Treatment:

Other: Proton Pump Inhibitor therapy only