| Trial registration number
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NCT04621058 |
Full text link
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04621058
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First author
Last imported at : July 17, 2022, 3:30 a.m.
Source : ClinicalTrials.gov
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Joaquín Durán Cantolla
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Contact
Last imported at : July 17, 2022, 3:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-11-09
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Recruitment status
Last imported at : July 17, 2022, 3:30 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- admitted to the respiratory or internal medicine units of santiago hospital (hua) due
to pneumonia.
- vitamin d deficiency (25(oh) defined by blood levels below 30 mg/ml.
- possibility for observation during the treatment period.
- signing of written consent (oral informed consent exceptionally).
- positive pcr for diagnosis of sars-cov2 infection
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Exclusion criteria
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- patients taking any type of vitamin d supplement.
- patients with hypoparathyroidism.
- pregnant or lactating women.
- patients in whom the administration of vitamin d is formally contraindicated (see
annex vi).
- patients who at time of inclusion, cannot take vitamin d orally.
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Number of arms
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Bioaraba Health Research Institute
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Inclusion age min
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Inclusion age max
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Spain
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Type of patients
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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108
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primary outcome
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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MORTALITY
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Notes
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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