Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-01-10 @ 10:55 AM
Study NCT ID:
NCT05244018
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2022-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D014807', 'term': 'Vitamin D'}], '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': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2022-01-29', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.', 'timeFrame': '7 days', 'description': 'Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations \\<20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission.\n* Expected to require mechanical ventilation for at least 72 hours after study entry.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* inability to obtain informed consent from the patient and/or legally authorized representative.\n* BMI\\> 40.\n* Pregnant or breastfeeding.\n* Chronic kidney diseases\n* Pancreatitis.\n* Hepatic insufficiency\n* Cases with coagulopathy\n* Moribund and not expected to survive 96 hours.\n* Ongoing shock\n* History of therapy with high dose vitamin D3 within previous 6 months.\n* History of disorders associated with hypercalcemia\n* Cancer as the cause of sepsis.\n* Subjects undergoing chemotherapy.\n* Immune compromised patients.\n* Pneumonia developed \\< 48 hours following intubation.\n* Patients with history of aspiration before intubation.\n* known allergy to vitamin D.'}, 'identificationModule': {'nctId': 'NCT05244018', 'briefTitle': 'Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FMASU MS 47/ 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1(Treatment group)', 'interventionNames': ['Drug: Vitamin D3 tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2(Control group)', 'interventionNames': ['Drug: Vitamin D tablets']}], 'interventions': [{'name': 'Vitamin D3 tablets', 'type': 'DRUG', 'description': 'Vitamin D3 tablets 50,000 IU units', 'armGroupLabels': ['Group 1(Treatment group)']}, {'name': 'Vitamin D tablets', 'type': 'DRUG', 'description': 'Vitamin D tablets 5000 units as daily requirements', 'armGroupLabels': ['Group 2(Control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain-Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.', 'investigatorFullName': 'Dr.Ibrahim Mamdouh Esmat', 'investigatorAffiliation': 'Ain Shams University'}}}}