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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-30

Study Completion Date

2029-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypovitaminosis b 12

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Oral Vitamin B12 Group

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.

Group Type EXPERIMENTAL

Cyanocobalamin 1000 Mcg Oral Tablet

Intervention Type DRUG

Oral cyanocobalamin supplement administered as a 1000 mcg tablet taken once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.

Sublingual Vitamin B12 Group

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.

Group Type EXPERIMENTAL

Cyanocobalamin 1000 Mcg Sublingual Tablet

Intervention Type DRUG

Sublingual cyanocobalamin supplement administered as a 1000 mcg tablet placed under the tongue once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.

Control Group (PPI 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.

Group Type ACTIVE_COMPARATOR

Proton Pump Inhibitor therapy only

Intervention Type OTHER

This group will continue their standard PPI therapy without receiving any vitamin B12 supplementation, serving as a control group for the comparison of B12 correction efficacy.

Interventions

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Cyanocobalamin 1000 Mcg Oral Tablet

Oral cyanocobalamin supplement administered as a 1000 mcg tablet taken once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.

Intervention Type DRUG

Cyanocobalamin 1000 Mcg Sublingual Tablet

Sublingual cyanocobalamin supplement administered as a 1000 mcg tablet placed under the tongue once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.

Intervention Type DRUG

Proton Pump Inhibitor therapy only

This group will continue their standard PPI therapy without receiving any vitamin B12 supplementation, serving as a control group for the comparison of B12 correction efficacy.

Intervention Type OTHER

Other Intervention Names

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Vitamin B12 tablet (oral) Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingual PPI, omeprazole, esomeprazole, pantoprazole

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes