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NCT Number: 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

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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Key information

Conditions

Hypovitaminosis b 12

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyanocobalamin 1000 Mcg Oral Tablet

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.

Other names: Vitamin B12 tablet (oral)

Cyanocobalamin 1000 Mcg Sublingual Tablet

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.

Other names: Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingual

Proton Pump Inhibitor therapy only

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.

Other names: PPI, omeprazole, esomeprazole, pantoprazole

Primary outcomes

Change in Serum Vitamin B12 Concentration

Time frame: Baseline and Week 6

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

Secondary outcomes

Change in Plasma Homocysteine Level

Time frame: Baseline and Week 6

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

Time frame: Baseline and Week 6

To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.
Patient-Reported Satisfaction with Route of Supplementation

Time frame: Week 6

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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: May 13, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.