Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 10:14 PM
Study NCT ID:
NCT06650293
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2024-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Serum bilirubin levels', 'timeFrame': '5 days', 'description': 'Total Serum bilirubin levels evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Jaundice']}, 'descriptionModule': {'briefSummary': 'Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Admitted between 3-28 days of age.\n* Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL\n* Born via either cesarean or vaginal delivery\n* Birth weight greater than 2500 grams\n\nExclusion Criteria:\n\n* Prior phototherapy treatment\n* Preterm birth (gestational age below 37 weeks).\n* SpO2 \\< 95% at the time of admission\n* Severe respiratory distress or failure\n* Neonatal sepsis\n* Congenital anomalies\n* Parents/guardians unwilling to let their neonates be part of this study.'}, 'identificationModule': {'nctId': 'NCT06650293', 'briefTitle': 'Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy', 'orgStudyIdInfo': {'id': 'UCHSL-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-A', 'description': 'Neonates receive phototherapy plus vitamin D', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'Group-B', 'description': 'Neonates will receive only phototherapy'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Vitamin D supplementation as vitamin D, 2 drops i.e., 800 IU daily for 5 days.', 'armGroupLabels': ['Group-A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': "Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore", 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Zeeshan Afzal, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore"}, {'name': 'Wajiha Rizwan, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': "Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}