Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 6:01 PM
Study NCT ID:
NCT07098234
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006932', 'term': 'Hyperbilirubinemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D010789', 'term': 'Phototherapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bilirubin reduction comparison', 'timeFrame': '72 hours', 'description': 'Net reductions in bilirubin levels in two groups after 72 hours were compared.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperbilirubinemia']}, 'descriptionModule': {'briefSummary': 'The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia.', 'detailedDescription': 'If vitamin-D has been found effective as an adjuvant to phototherapy in the treatment of exaggerated physiological hyperbilirubinemia, it may help to reduce the serum bilirubin level rapidly. It may also reduce the complications by shortening the duration of phototherapy to offer better patient compliance and better patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns of any gender\n* Age of 3rd day of life to 8th day of life\n* Gestation age ≥37 to ≤42 weeks\n* Total serum bilirubin level more than 12.9 mg/dL\n* Weight \\> 2.5 kg\n\nExclusion Criteria:\n\n* Congenital defects (on physical examination)\n* Large for gestational age infant\n* Rh Incompatibility (were excluded on basis of blood grouping of mother and baby)\n* ABO Incompatibility (were excluded on basis of blood grouping of mother and baby)\n* Neonatal sepsis'}, 'identificationModule': {'nctId': 'NCT07098234', 'briefTitle': 'Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.', 'orgStudyIdInfo': {'id': 'Dr-Hafsah-LHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3 group', 'description': 'Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy.', 'interventionNames': ['Drug: Vitamin D3', 'Procedure: Phototherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phototherapy group', 'description': 'Neonates received only phototherapy for 72 hours.', 'interventionNames': ['Procedure: Phototherapy']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'description': 'Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours as an adjuvant therapy to phototherapy.', 'armGroupLabels': ['Vitamin D3 group']}, {'name': 'Phototherapy', 'type': 'PROCEDURE', 'description': 'Neonates received only phototherapy until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours.', 'armGroupLabels': ['Phototherapy group', 'Vitamin D3 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Mayo Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Hafsah Naz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Hospital, Lahore, Pakistan'}, {'name': 'Muhammad Ashfaq', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Hospital, Lahore, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}