Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT04449718
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2020-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation in Patients With 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': '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospitalization', 'timeFrame': 'From date of randomization until the date of hospital discharge or death, which is usually less than 1 month', 'description': 'total number of days that patient remained hospitalized'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From date of randomization until the date of hospital discharge or death, which is usually less than 1 month', 'description': 'number of patients that died'}, {'measure': 'Number of cases admitted to Intensive Care Unit (ICU)', 'timeFrame': 'From date of randomization until the date of hospital discharge or death, which is usually less than 1 month', 'description': 'total number of days that patient remained in ICU'}, {'measure': 'Length of use of mechanic ventilator', 'timeFrame': 'From date of randomization until the date of hospital discharge or death, which is usually less than 1 month', 'description': 'total number of days that patient remained in mechanic ventilator'}, {'measure': 'Number and severity of symptoms', 'timeFrame': 'From date of randomization until the date of hospital discharge or death, which is usually less than 1 month'}, {'measure': 'Inflammatory markers', 'timeFrame': 'Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)', 'description': 'C-reactive protein, IL-1alpha (pg/ml), IL-1beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml), IL-1ra (pg/ml), IL-10 (pg/ml) concentration in the serum'}, {'measure': 'C-reactive protein', 'timeFrame': 'Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)', 'description': 'serum concentration'}, {'measure': 'Vitamin D', 'timeFrame': 'Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)', 'description': 'serum concentration'}, {'measure': 'Creatinine', 'timeFrame': 'Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)', 'description': 'serum concentration'}, {'measure': 'Calcium', 'timeFrame': 'Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)', 'description': 'serum concentration'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline', 'description': 'Baecke questionnaire (higher scores mean a higher physical activity level)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'vitamin D', 'acute respiratory syndrome'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '39208655', 'type': 'DERIVED', 'citation': 'Sales LP, Souza LVB, Fernandes AL, Murai IH, Santos MD, Vendramini MBG, Oliveira RM, Figueiredo CP, Caparbo VF, Gualano B, Pereira RMR; in memoriam. Effect of vitamin D3 on antiphospholipid antibodies in hospitalized patients with moderate to severe COVID-19. Clinics (Sao Paulo). 2024 Aug 27;79:100474. doi: 10.1016/j.clinsp.2024.100474. eCollection 2024.'}, {'pmid': '38702342', 'type': 'DERIVED', 'citation': 'Fernandes LP, Murai IH, Fernandes AL, Sales LP, Rogero MM, Gualano B, Barroso LP, Milne GL, Pereira RMR, Castro IA. The severity of COVID-19 upon hospital admission is associated with plasma omega-3 fatty acids. Sci Rep. 2024 May 3;14(1):10238. doi: 10.1038/s41598-024-60815-y.'}, {'pmid': '36176639', 'type': 'DERIVED', 'citation': 'Fernandes AL, Sales LP, Santos MD, Caparbo VF, Murai IH, Pereira RMR. Persistent or new symptoms 1 year after a single high dose of vitamin D3 in patients with moderate to severe COVID-19. Front Nutr. 2022 Sep 13;9:979667. doi: 10.3389/fnut.2022.979667. eCollection 2022.'}, {'pmid': '35020796', 'type': 'DERIVED', 'citation': 'Fernandes AL, Murai IH, Reis BZ, Sales LP, Santos MD, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. Effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in patients with moderate to severe COVID-19. Am J Clin Nutr. 2022 Mar 4;115(3):790-798. doi: 10.1093/ajcn/nqab426.'}, {'pmid': '34852148', 'type': 'DERIVED', 'citation': 'Murai IH, Fernandes AL, Antonangelo L, Gualano B, Pereira RMR. Effect of a Single High-Dose Vitamin D3 on the Length of Hospital Stay of Severely 25-Hydroxyvitamin D-Deficient Patients with COVID-19. Clinics (Sao Paulo). 2021 Nov 26;76:e3549. doi: 10.6061/clinics/2021/e3549. eCollection 2021.'}, {'pmid': '34029377', 'type': 'DERIVED', 'citation': 'Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.'}, {'pmid': '33595634', 'type': 'DERIVED', 'citation': 'Murai IH, Fernandes AL, Sales LP, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Reis BZ, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1053-1060. doi: 10.1001/jama.2020.26848.'}]}, 'descriptionModule': {'briefSummary': 'Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of flu syndrome with hospitalization criteria;\n* Respiratory rate ≥ 24irpm and / or saturation \\<93% in room air, or belonging to the risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary tuberculosis; 4. Obesity;\n* Tomographic findings compatible with coronavirus disease.\n\nExclusion Criteria:\n\n* Patient admitted already under invasive mechanical ventilation;\n* Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;\n* Prior vitamin D supplementation (above 1000 IU/day);\n* Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;\n* Admitted patients with expected hospital discharge in less than 24 hours;\n* Patient unable to sign the consent form.'}, 'identificationModule': {'nctId': 'NCT04449718', 'briefTitle': 'Vitamin D Supplementation in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '30959620.4.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients will receive 200,000 IU of vitamin D3 on admission + conventional care', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive an equivalent amount of a placebo solution on admission + conventional care', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': '200,000 IU on admission', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '200,000 IU on admission', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinical Hospital of the School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rosa Pereira, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine, University of Sao Paulo'}, {'name': 'Bruno Gualano, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Medicine, University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'ROSA MARIA RODRIGUES PEREIRA', 'investigatorAffiliation': 'University of Sao Paulo'}}}}