Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT04621058
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2020-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Vitamin D Treatment in Mortality Reduction Due to COVID-19.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple-blind study, neither the patients, nor the researchers, nor those responsible for the statistical analysis will know the treatment that the patient is undergoing.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MORTALITY', 'timeFrame': 'At 21 days.', 'description': 'Mortality reduction'}], 'secondaryOutcomes': [{'measure': 'Intensive care admissions', 'timeFrame': 'At 21 days', 'description': 'Intensive care admissions reduction'}, {'measure': 'Length of hospital stay', 'timeFrame': 'AT 21 DAYS', 'description': 'Length of hospital stay reduction'}, {'measure': 'Prevalence of vitamin D deficiency', 'timeFrame': 'At baseline', 'description': 'To assess the prevalence of vitamin D deficiency at baseline'}, {'measure': 'Incremental cost effectiveness ratio (ICER)', 'timeFrame': 'At 21 days', 'description': 'To calculate the incremental cost per event (mortality) avoided'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SAR', 'SARS Pneumonia']}, 'descriptionModule': {'briefSummary': 'HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.\n\nOBJECTIVES:\n\nPRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.\n\nSECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.\n\nMETHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.', 'detailedDescription': 'HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.\n\nOBJECTIVES:\n\nPRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.\n\nSECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.\n\nMETHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.\n\nInclusion criteria: Adult patients admitted to the Respiratory/Internal Medicine Unit of Santiago hospital of the OSI Araba HUA for acute pneumonia and suffering from a vitamin D deficit (\\< 30 ng/ml) and a RT-PCR, in nasopharyngeal exudate, positive for SARS-CoV-2.\n\nExclusion criteria: 1)Patients taking any type of vitamin D supplement. 2)Patients with hypoparathyroidism. 3) Patients in whom the administration of vitamin D is formally contraindicated. 4) Patients who cannot take vitamin D orally.\n\nOUR SIZE: In order to answer to the main objective (mortality reduction 21% versus 50% intervention and control group respectively), we will need a total sample of 108 evaluable subjects-54 patients per group (J Crit Care. 2018;44:300-5).Statistical power 90%,95% statistical significance with possible loss of follow-up of 5% of patients.\n\nA recruitment period of about 12 months is needed.\n\nSTATISTICAL ANALYSIS: In order to answer to the main and secondary objectives (mortality and ICU admission), the Chi-square test will be performed and in the event that any of the frequencies is less than 5, the exact Fisher test will be used.\n\nDepending on the distribution of the quantitative variables, the Student t-test for independent samples or the non-parametric Mann-Whitney U-test will be used, respectively.\n\nThe analysis criterion will be "by intention to treat". In all cases. The statistical significance will be 95%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia.\n* Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/ml.\n* Possibility for observation during the treatment period.\n* Signing of written consent (oral informed consent exceptionally).\n* Positive PCR for diagnosis of sars-cov2 infection\n\nExclusion Criteria:\n\n* Patients taking any type of vitamin D supplement.\n* Patients with hypoparathyroidism.\n* Pregnant or lactating women.\n* Patients in whom the administration of vitamin D is formally contraindicated (see annex VI).\n* Patients who at time of inclusion, cannot take vitamin D orally.'}, 'identificationModule': {'nctId': 'NCT04621058', 'briefTitle': 'Efficacy of Vitamin D Treatment in Mortality Reduction Due to COVID-19.', 'organization': {'class': 'NETWORK', 'fullName': 'Bioaraba Health Research Institute'}, 'officialTitle': 'Efficacy of Treatment With Vitamin D in Patients Diagnosed With COVID-19 Who Presenting Vitamin D Deficiency and Pneumonia.', 'orgStudyIdInfo': {'id': 'VITD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D VITAMIN GROUP', 'description': 'The administration of vitamin D will be carried out using the following treatment scheme:\n\nIf vitamin D deficiency (\\< 30 ng/ml) treatment with 2 capsules of 0.266 mg If vitamin D deficiency (\\< 40 ng/ml): treatment with 1 capsule of 0.266 mg\n\nBlood levels of vitamin D will be determined on day 1, 4, 7 and 14. Based on the results from day 14, a new determination is recommended 4 weeks after starting treatment with the primary care physician who will decide whether to continue or interrupt the treatment. This phase will be carried out outside of the study.\n\nIn addition, the product should only be administered, if blood calcium and phosphorus levels are within normal limits, as well as if the creatinuria/calciuria ratio is within normal ranges.', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO GROUP', 'description': 'The procedure will be the same as in the experimental group but instead of the active component, patients will take placebo capsules exactly the same as above but without the active component.', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['D VITAMIN GROUP'], 'description': 'In case of Vitamin D levels \\<30 or 40ng/ml patients will take vitamin D supplements.', 'armGroupLabels': ['D VITAMIN GROUP']}, {'name': 'PLACEBO', 'type': 'DRUG', 'otherNames': ['PLACEO GROUP'], 'description': 'Placebo capsules exactly the same as the above, but without the active component.', 'armGroupLabels': ['PLACEBO GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01002', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Joaquín Durán Cantolla', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Joaquín Durán Cantolla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bioaraba Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioaraba Health Research Institute', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Fundación Eduardo Anitua', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}