| Trial registration number
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NCT05384574 |
Full text link
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05384574
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First author
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Lenko Saric
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Contact
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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2022-05-20
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Recruitment status
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Not recruiting
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Study design
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 21, 2022, 9:30 a.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 : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
patients admitted to icu with severe covid-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin d (<50 nmol/l) measured on admission. all patients are older than 18 years and have confirmed covid-19 disease with pcr test.
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Exclusion criteria
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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patients will be excluded from study in case of calcium levels that are consistently above normal serum range (> 2.6 mmol/l, > 10.5 mg/dl) or if vitamin d levels are > 150 nmol/l.
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Number of arms
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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University Hospital of Split
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Inclusion age min
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Croatia
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Type of patients
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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200
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primary outcome
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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number of days on mechanical ventilation
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Notes
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 21, 2022, 9:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : May 21, 2022, 9:30 a.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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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