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| Column | Value |
|---|---|
| Trial registration number | NCT05166005 |
|
Full text link
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
2021-12-21 |
|
Recruitment status
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: males and females aged 18 to 75 years who did not take vitamin d supplementation covid-19 clinical features signed informed consent to participate in the research. |
|
Exclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
pregnancy or nursing primary hyperparathyroidism or hypercalcemia other etiologies (including 24-hydroxylase mutation) a history of granulomatous diseases severe gastrointestinal diseases (clinically apparent malabsorption syndrome) liver disease kidney disease individual intolerance drug vitamin d supplementation in a dose of more than 800 iu per drugs known to affect vitamin d metabolism (e.g., anticonvulsants, glucocorticoids, diuretics) alcohol and drug addiction. history of cancer (less than 5 years) |
|
Number of arms
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
|
Inclusion age min
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
75 |
|
Countries
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Russia |
|
Type of patients
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
350 |
|
primary outcome
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Combined: severity, ICU hospitalization, outcome of the disease on 14-21 days |
|
Notes
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "low dose", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "High dose", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}] |