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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Vitamin B12 Group | Experimental | 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. |
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| Sublingual Vitamin B12 Group | Experimental | 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 6 |
| Change in Hemoglobin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| 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. |
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| 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. |
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To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.
| 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). | Week 6 |
| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D013607 | Tablets |
| D000286 | Administration, Sublingual |
| D009853 | Omeprazole |
| D064098 | Esomeprazole |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D000284 | Administration, Oral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
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