| Trial registration number
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NCT04952857 |
Full text link
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04952857
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First author
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Ashu Rastogi
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Contact
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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2021-07-07
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Recruitment status
Last imported at : Dec. 23, 2021, 3:30 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : July 8, 2021, 4 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 : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
rt-pcr proven sars-cov-2 infection or computed tomography scan findings compatible with the covid19 disease (bilateral multifocal ground-glass opacities ≥50%)
moderate to severe covid-19 defined by pfr ratio of <200
sofa score>4
patients with vitamin d deficiency defined as 25 (oh)d level<20 ng/ml
age>18 years
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Exclusion criteria
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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- 1. vitamin d sufficient or already receiving vitamin d supplements 2. active
malignancy 3. hypercalcemia, hyperparathyroidism 4. chronic kidney disease (egfr<30
ml/min) 5. pregnant and lactating women 6. patient on mechanical ventilation at icu
admission
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Number of arms
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : March 31, 2024, midnight
Source : ClinicalTrials.gov
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Post Graduate Institute of Medical Education and Research, Chandigarh
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Inclusion age min
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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80
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Countries
Last imported at : Aug. 13, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
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India
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Type of patients
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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90
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primary outcome
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Sequential Organ Failure Assessment (SOFA)
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Notes
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : July 8, 2021, 4 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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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