Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-31 @ 4:11 PM
Study NCT ID:
NCT06964334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cure rate after treatment', 'timeFrame': '3 months', 'description': 'compare cure rate between two groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Helicobacter pylori (H. pylori) is one of the most common chronic infections worldwide. The mode of transmission of H. pylori is through the fecal-oral or oral-oral routes.\n\nChronic gastritis has been linked to helicobacter pylori (H. pylori) infection. Peptic ulcer disease, gastric adenocarcinoma, and gastric lymphoma are all linked to this condition .\n\nIn Egypt, a high prevalence of H. pylori infections has been reported, ranging from 70% in the general population , 73% among school children , up to 88% in patients with chronic active HCV .\n\nIn 2007, the American College of Gastroenterology estimated that the cure rate for H. pylori infections was 70-85 percent with the use of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole .\n\nchildren with H. pylori infection do not have severe digestive symptoms. pylori infection represents a key factor in the pathogenesis of duodenal ulcer and chronic gastritis in children. In addition, H. pylori infection has also been reported to have extra-digestive consequences .\n\nA recent comprehensive evaluation found that sequential and conventional triple treatment had a cure rate of 84% .\n\nThe infected macrophage is unable to create enough 1,25-(OH)2D to control the synthesis of AMP cathelicidin when it is vitamin D deficient .\n\nvitamin D has a powerful systemic antibacterial impact by enhancing the activity of monocytes and macrophages. Most illnesses seem to benefit from a vitamin D-rich condition .\n\nVitamin D-deficient subjects might be more prone to developing H. pylori infection .', 'detailedDescription': 'To assess the efficacy of adding vitamin D supplement as adjuvant therapy in eliminating helicobacter pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 1 to 16 years old who present with helicobacter pylori infection diagnosed by positive stool antigen test for helicobacter pylori infection presented with weight loss, abdominal pain, or failure to surive symptoms for at least 1 month.\n\nExclusion Criteria:\n\n\\- 1. Known hypersensitivity to PPIS or antibiotics. 2. Patients who have previously received helicobacter pylori eradication treatment, corticosteroids/immunosuppressive treatment and acid suppressive treatment in the prior 2 months.\n\n3\\. History of systemic inflammatory or autoimmune disorders, gastric surgery, renal failure, liver cirrhosis and malignancies 4. Abnormal birth history such as premature birth and asphyxia or with severe disease history, such as genetic metabolic disease, congenital dysplasia, feeding difficulties, severe malnutrition, repeated respiratory diseases.'}, 'identificationModule': {'nctId': 'NCT06964334', 'briefTitle': 'The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': 'vit D supplement h.pylori'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and vitamin D supplement.', 'interventionNames': ['Drug: Lansoprazole', 'Drug: amoxicillin', 'Drug: clarithromycin', 'Drug: vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'include 35 patients with helicobacter pylori infection with clarithromycin based triple therapy and without vit D supplement.', 'interventionNames': ['Drug: Lansoprazole', 'Drug: amoxicillin', 'Drug: clarithromycin']}], 'interventions': [{'name': 'Lansoprazole', 'type': 'DRUG', 'description': 'oral lansoprazole (1 mg/kg per day, max. 30 mg bid)for 14 day', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'amoxicillin', 'type': 'DRUG', 'description': 'amoxicillin (50 mg/kg per day, max. 1 g bid) for 14 day', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'clarithromycin', 'type': 'DRUG', 'description': 'oral clarithromycin (15 mg/kg per day, max. 500 mg bid) for 14 day', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'vitamin D', 'type': 'DRUG', 'description': 'vitamin D therapy of 4000-5000 units daily in patients over 12 months old.', 'armGroupLabels': ['Group A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor', 'investigatorFullName': 'Ahmed Samy Abdelsamie Sayed', 'investigatorAffiliation': 'Assiut University'}}}}