[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590395":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":45,"locations":45,"responsibleParty":46,"collaborators":45,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":45,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":45,"enrollmentInfo":60,"targetDuration":45,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":45,"overallStatus":69,"whyStopped":45,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":45},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Cyanocobalamin 1000 Mcg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Sublingual Vitamin B12 Group","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.",[18],"Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet",{"label":20,"type":21,"description":22,"interventionNames":23},"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.",[24],"Other: Proton Pump Inhibitor therapy only",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[9],[32],"Vitamin B12 tablet (oral)",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"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.",[15],[38],"Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingual",{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"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.",[20],[44],"PPI, omeprazole, esomeprazole, pantoprazole",null,{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Reem Alaa Abdel Samie","teacher assistant in Delta University for science and technology","100590395","phase-3-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-100590395",false,"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","Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study","Inclusion Criteria:\n\n* Age 18-70.\n* PPI use for 1-6 months (new users).\n* Serum B12 between 150-300 pg\u002FmL.\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\u002Fbariatric surgery.\n* Baseline anemia with hemoglobin \\\u003C9 g\u002FdL.\n* Severe renal or liver failure.",true,"ALL","18 Years",{"count":61,"type":62},23,"ESTIMATED","INTERVENTIONAL",[65],"PHASE3","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.",[68],"Hypovitaminosis b 12","NOT_YET_RECRUITING","2025-05-04",{"date":72,"type":73},"2025-05-13","ACTUAL",{"date":75,"type":62},"2026-12-30",{"date":77,"type":62},"2029-12-30",{"name":5,"class":6}]