Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT04738760
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'Two weeks', 'description': 'Length of hospital stay'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Two weeks', 'description': 'Death during hospitalization'}, {'measure': 'Clinical status improvement using six category ordinal scale', 'timeFrame': 'Two weeks', 'description': 'Change in six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death.'}, {'measure': 'Change in gas exchange', 'timeFrame': 'Two weeks', 'description': 'Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge'}, {'measure': 'Time to increase in oxygenation', 'timeFrame': '48 hours', 'description': 'Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)'}], 'secondaryOutcomes': [{'measure': 'Change in Lactate dehydrogenase (LDH) levels', 'timeFrame': 'Two weeks', 'description': 'Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge'}, {'measure': 'Change in C-reactive protein (CRP) levels', 'timeFrame': 'Two weeks', 'description': 'Change in levels of C-reactive protein (CRP) between baseline and before discharge'}, {'measure': 'Change in serum ferritin levels', 'timeFrame': 'Two weeks', 'description': 'Change in levels of serum ferritin between baseline and before discharge'}, {'measure': 'Occurrence of secondary infection', 'timeFrame': 'Two weeks', 'description': 'Occurrence of sepsis'}, {'measure': 'Occurrence of at least one severe adverse event', 'timeFrame': 'Two weeks', 'description': 'Any serious or severe adverse event that might happens during hospital stay'}, {'measure': 'Need for mechanical ventilator or intensive care unit (ICU) support', 'timeFrame': 'Two weeks', 'description': 'Admission to ICU or usage of mechanical ventilator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Cytokine Storm', 'Vitamin D'], 'conditions': ['Covid19', 'Corona Virus Infection', 'Cytokine Storm', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.\n\nAdditionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects.\n\nIn addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate.\n\nThe objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients received the same background treatment for 5 days, following an Institutional protocol for standard of care: hydroxychloroquine 400 mg daily, lopinavir/ritonavir 400/100 mg twice daily or/and remdisivir 200 mg LD then 100 once daily as a maintenance dose and anti-coagulation prophylaxis with enoxaparin subcutaneously once a day if D-dimmer between 500-1000 or enoxaparin therapeutic subcutaneously twice daily if D-dimmer \\>1000.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 65 years.\n2. COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.\n3. RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.\n4. Presence of acute respiratory distress syndrome (ARDS).\n5. Having either peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.\n\nExclusion Criteria:\n\n1. Vitamin D supplementation in the previous month.\n2. Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.\n3. Organ failure requiring admission to a resuscitation or high dependency unit.\n4. Pregnant women.\n5. Participation in another simultaneous clinical trial.'}, 'identificationModule': {'nctId': 'NCT04738760', 'briefTitle': 'Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients', 'orgStudyIdInfo': {'id': 'COVID-VIT-D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Moderate and severe patients who were infected with SARS-CoV-2 and who were already receiving treatment with standard dose vitamin D in addition to standard COVID-19 management.'}, {'label': 'Group 2', 'description': 'Moderate and severe patients who were infected with SARS-CoV-2 and who were already receiving treatment with high dose vitamin Din addition to standard COVID-19 management.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11314', 'city': 'Cairo', 'state': 'Please Select', 'country': 'Egypt', 'facility': 'Teachers Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Neven Sarhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Misr International University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at Faculty of Pharmacy', 'investigatorFullName': 'Neven Sarhan', 'investigatorAffiliation': 'Misr International University'}}}}