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

What Was Tested

In this phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

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.

It had three arms (groups): Oral Vitamin B12 Group (experimental), Sublingual Vitamin B12 Group (experimental) and Control Group (PPI Only) (active comparator).

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.

The registry classes the interventions as drug and other.

Who Took Part

23 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: PPI use for 1-6 months (new users). Serum B12 between 150-300 pg/mL. No known prior B12 supplementation.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of long-term gi disease (e.g., crohn's, celiac); previous gastrectomy/bariatric surgery; severe renal or liver failure.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant and care provider.

It started in 2026-12-30 with completion listed for 2028-12-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Serum Vitamin B12 Concentration (time frame: Baseline and Week 6).

It also tracked 3 secondary outcomes, for example Change in Plasma Homocysteine Level, Change in Hemoglobin Level and Patient-Reported Satisfaction with Route of Supplementation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 23 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.