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 3Not Yet RecruitingNCT06966856

Tanta University23 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypovitaminosis b 12

Interventions

Cyanocobalamin 1000 Mcg Oral TabletDRUG

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.

Cyanocobalamin 1000 Mcg Sublingual TabletDRUG

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.

Proton Pump Inhibitor therapy onlyOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Serum Vitamin B12 Concentration

Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.

Time frame: Baseline and Week 6

Secondary Outcomes

Change in Plasma Homocysteine Level

Plasma homocysteine levels will be measured at baseline and at 6 weeks to assess the functional improvement in vitamin B12 status.

Time frame: Baseline and Week 6

Change in Hemoglobin Level

To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.

Time frame: Baseline and Week 6

Patient-Reported Satisfaction with Route of Supplementation

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).

Time frame: Week 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.