Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT06176157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-09', 'studyFirstSubmitDate': '2023-12-09', 'studyFirstSubmitQcDate': '2023-12-09', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum 25(OH) D level after 1,2,3 months of supplementation', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets\n\nExclusion Criteria:\n\n* vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.'}, 'identificationModule': {'nctId': 'NCT06176157', 'briefTitle': 'Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'FMASU MS468/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oral vitamin D2 group', 'interventionNames': ['Dietary Supplement: vitamin D2, vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral vitamin D3 group', 'interventionNames': ['Dietary Supplement: vitamin D2, vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parenteral vitamin D2 group', 'interventionNames': ['Dietary Supplement: vitamin D2, vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parenteral vitamin D3 group', 'interventionNames': ['Dietary Supplement: vitamin D2, vitamin D3']}], 'interventions': [{'name': 'vitamin D2, vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'comparing parentral D2, D3, to oral D2, D3', 'armGroupLabels': ['Parenteral vitamin D2 group', 'Parenteral vitamin D3 group', 'oral vitamin D2 group', 'oral vitamin D3 group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa M Nawar, Lecturer', 'role': 'CONTACT', 'email': 'marwa_magdy@med.asu.edu.eg', 'phone': '+201005368647'}, {'name': 'Heba H ELsedfy, professor', 'role': 'CONTACT', 'email': 'hebased@yahoo.com', 'phone': '+201005189166'}], 'overallOfficials': [{'name': 'Marwa M Nawar, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After Publishing the research individual data will be available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatric Endocrinology, Faculty of Medicine', 'investigatorFullName': 'Marwa Magdy Hassan Nawar', 'investigatorAffiliation': 'Ain Shams University'}}}}