| Trial registration number
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EUCTR2020-001793-30-DK |
Full text link
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001793-30/DK
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First author
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Department of Cardiologi, Copenhagen University Hospital of Bispebjerg - Ahmad Sajadieh
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Contact
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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ahmad.sajadieh@regionh.dk
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Registration date
Last imported at : Aug. 26, 2024, 8 p.m.
Source : EU Clinical Trials Register
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2020-05-24
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Recruitment status
Last imported at : March 15, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Terminated
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Study design
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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RCT
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Allocation
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Randomized
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Design
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Blind label
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Center
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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multi-center
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Study aim
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Treatment
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Inclusion criteria
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1 Age>=50 years
2 Positive test for SARS-COV-2
3 Signed informed Consent
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Exclusion criteria
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1) Need for immediate hospital admission
2) Known hypercalcemia or hyperparathyroidism
3) Significant kidney disease needing dialysis
4) Known kidney stone or nephrocalcinosis
5) Pregnancy or no-anti-conception in fertile women*
6) Regular user of supplemental Vitamin D (>=20 µg /day > one month) or
7) Known intolerance to Vitamin D
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Number of arms
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Copenhagen University Hospital of Bispebjerg
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Inclusion age min
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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50
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Inclusion age max
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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100
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Countries
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Denmark
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Type of patients
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Mild disease at enrollment
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Severity scale
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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1: Mild disease at enrollment
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Total sample size
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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480
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primary outcome
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Disease aggravation defined as: Combined endpoint of death and duration of hospitalization, calculated as Days Alive and Out of Hospital (DAOH) in a Time Frame of 6 weeks (42 days).
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Notes
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Declared number of arm (3.0)
differs from found arms (2.0)
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Phase
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
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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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