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Not yet recruiting NCT06966856

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 III Interventional Hypovitaminosis b 12

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyanocobalamin 1000 Mcg Oral Tablet, Cyanocobalamin 1000 Mcg Sublingual Tablet, Proton Pump Inhibitor therapy only.
Who it may be relevant to
Registry conditions: Hypovitaminosis b 12. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study

Overview

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.

Interventions

  • Drug 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.
  • 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.
  • Other 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.

Primary outcome measures

  • Change in Serum Vitamin B12 Concentration [Time frame: Baseline and Week 6]
Secondary outcome measures (3)
  • Change in Plasma Homocysteine Level [Time frame: Baseline and Week 6]
  • Change in Hemoglobin Level [Time frame: Baseline and Week 6]
  • Patient-Reported Satisfaction with Route of Supplementation [Time frame: Week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06966856 · ORSUB12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗