Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-22 @ 3:42 AM
Study NCT ID:
NCT04552951
Status:
UNKNOWN
Last Update Posted:
2020-09-17
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D on Morbidity and Mortality of the COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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'}]}, '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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Time to death or hospital discharge in days (average 12 days)', 'description': 'Percentage of patients dying during hospitalization'}, {'measure': 'Admission to Intensive Care Unit (ICU)', 'timeFrame': 'Time from hospital admission to discharge in days (average 12 days)', 'description': 'Percentage of patients admitted to ICU and time in ICU'}, {'measure': 'Time of hospitalization', 'timeFrame': 'Time of hospitalization in days (average 12 days)', 'description': 'Number of days from hospital admission to discharge'}, {'measure': 'Clinical changes', 'timeFrame': 'At the time of hospital admission and discharge (average 12 days)', 'description': 'Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...)'}, {'measure': 'Radiological changes', 'timeFrame': 'At the time of hospital admission and discharge (average 12 days)', 'description': 'Changes in the percentage of patients with radiological findings of pneumonia and severity'}, {'measure': 'Calcidiol changes', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Calcidiol levels in ng/mL.'}, {'measure': 'Inflammation markers changes (CRP)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'C-reactive protein (CRP) in mg/L'}, {'measure': 'Inflammation markers changes (IL-6)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Interleukin-6 (IL-6) in pg/mL'}, {'measure': 'Inflammation markers changes (Leucocytes)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Leucocytes in cells per liter'}, {'measure': 'Inflammation markers changes (D-dimer)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'D-dimer in µg/mL'}, {'measure': 'General biochemical parameters changes (Creatinine)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Creatinine in mg/dL'}, {'measure': 'General biochemical parameters changes (Ferritin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Ferritin in µg/L'}, {'measure': 'General biochemical parameters changes (Bilirubin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Bilirubin in mg/dL'}, {'measure': 'General biochemical parameters changes (Albumin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Albumin in g/dL'}, {'measure': 'General biochemical parameters changes (Haemoglobin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Haemoglobin in g/dL'}, {'measure': 'General biochemical parameters changes (HDL cholesterol)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'High density lipoprotein (HDL cholesterol) in mg/dL'}, {'measure': 'General biochemical parameters changes (Procalcitonin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Procalcitonin in ng/mL'}, {'measure': 'General biochemical parameters changes (Protonin)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Protonin in ng/L'}, {'measure': 'General biochemical parameters changes (Calcium)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Calcium in mg/dL'}, {'measure': 'General biochemical parameters changes (Phosphate)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'Phosphate in mg/dL'}, {'measure': 'General biochemical parameters changes (pO2)', 'timeFrame': 'At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)', 'description': 'pO2 in mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '35177066', 'type': 'DERIVED', 'citation': 'Cannata-Andia JB, Diaz-Sottolano A, Fernandez P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-Lopez N, Panizo S, Ibanez GH, Cusumano CA, Ballarino C, Sanchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calvino-Varela J, Gomez MD, Gomez-Alonso C, Cunningham J, Naves-Diaz M, Douthat W, Fernandez-Martin JL; COVID-VIT-D trial collaborators. A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial. BMC Med. 2022 Feb 18;20(1):83. doi: 10.1186/s12916-022-02290-8.'}]}, 'descriptionModule': {'briefSummary': 'Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).\n\nClinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.', 'detailedDescription': 'Efficacy parameters to compare both groups (vitamin D and No vitamin D).\n\nTime to reach undetectable levels of SARS COV2 Infection.\n\nTime of normalization of symptoms and clinical parameters.\n\nTime of normalization of radiological images.\n\nTime of normalization of biochemical markers.\n\nTime of normalization of molecular inflammatory markers.\n\nTransfer to the Intensive care Unit.\n\nMortality rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 year\n* Diagnosis of COVID-19\n* Accept to participate in the study ( consent)\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy to vitamin D\n* Consumption of any form of vitamin D during the last 3 months\n* Expected fatal outcome in the next 24 hours\n* Cognitive deterioration'}, 'identificationModule': {'nctId': 'NCT04552951', 'acronym': 'COVID-VIT-D', 'briefTitle': 'Effect of Vitamin D on Morbidity and Mortality of the COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación Biosanitaria del Principado de Asturias'}, 'officialTitle': 'Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias', 'orgStudyIdInfo': {'id': '2020-019-PF-CAANJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed', 'interventionNames': ['Drug: Cholecalciferol']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No vitamin D'}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'Single doe of 100.000 IU', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge B Cannata-Andía, MD PhD', 'role': 'CONTACT', 'email': 'cannata@hca.es', 'phone': '*34 985106137'}, {'name': 'Juan Pérez-Ortega', 'role': 'CONTACT', 'email': 'juan.perez@finba.es', 'phone': '*34 985 109905'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'centralContacts': [{'name': 'Jorge B Cannata-Andía, MD PhD', 'role': 'CONTACT', 'email': 'cannata@hca.es', 'phone': '*34 985 106137'}, {'name': 'Juan Pérez-Ortega', 'role': 'CONTACT', 'email': 'juan.perez@finba.es', 'phone': '*34 985109905'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación Biosanitaria del Principado de Asturias', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria del Principado de Asturias', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}