Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT06966856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000286', 'term': 'Administration, Sublingual'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000284', 'term': 'Administration, Oral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-04', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Vitamin B12 Concentration', 'timeFrame': 'Baseline and Week 6', 'description': 'Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.'}], 'secondaryOutcomes': [{'measure': 'Change in Plasma Homocysteine Level', 'timeFrame': 'Baseline and Week 6', 'description': 'Plasma homocysteine levels will be measured at baseline and at 6 weeks to assess the functional improvement in vitamin B12 status.'}, {'measure': 'Change in Hemoglobin Level', 'timeFrame': 'Baseline and Week 6', 'description': 'To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.'}, {'measure': 'Patient-Reported Satisfaction with Route of Supplementation', 'timeFrame': 'Week 6', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypovitaminosis b 12']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-70.\n* PPI use for 1-6 months (new users).\n* Serum B12 between 150-300 pg/mL.\n* No known prior B12 supplementation.\n\nExclusion Criteria:\n\n* History of long-term GI disease (e.g., Crohn's, celiac).\n* Previous gastrectomy/bariatric surgery.\n* Baseline anemia with hemoglobin \\<9 g/dL.\n* Severe renal or liver failure."}, 'identificationModule': {'nctId': 'NCT06966856', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'ORSUB12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Vitamin B12 Group', 'description': '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.', 'interventionNames': ['Drug: Cyanocobalamin 1000 Mcg Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Sublingual Vitamin B12 Group', 'description': '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.', 'interventionNames': ['Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (PPI Only)', 'description': '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.', 'interventionNames': ['Other: Proton Pump Inhibitor therapy only']}], 'interventions': [{'name': 'Cyanocobalamin 1000 Mcg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Vitamin B12 tablet (oral)'], 'description': '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.', 'armGroupLabels': ['Oral Vitamin B12 Group']}, {'name': 'Cyanocobalamin 1000 Mcg Sublingual Tablet', 'type': 'DRUG', 'otherNames': ['Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingual'], 'description': '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.', 'armGroupLabels': ['Sublingual Vitamin B12 Group']}, {'name': 'Proton Pump Inhibitor therapy only', 'type': 'OTHER', 'otherNames': ['PPI, omeprazole, esomeprazole, pantoprazole'], 'description': '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.', 'armGroupLabels': ['Control Group (PPI Only)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teacher assistant in Delta University for science and technology', 'investigatorFullName': 'Reem Alaa Abdel Samie', 'investigatorAffiliation': 'Tanta University'}}}}