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Trial - NCT05415254


Column Value
Trial registration number NCT05415254
Full text link
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05415254

First author
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Jing Ma, Dr.

Contact
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

cherry1996@live.cn

Registration date
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

2022-06-13

Recruitment status
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: hospitalized symptomatic covid-19 patients; covid-19 nucleic acid ct value < 28 (both orf1ab gene ct value and n gene ct value < 28); vitamin d deficiency: 25ohd ≤ 20ng/ml; age: 18-70 years old;

Exclusion criteria
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

asymptomatic covid-19 patients ； hypercalcemia; history of primary hyperparathyroidism; history of triple hyperparathyroidism; patients who are allergic to calcitriol; pregnant or lactating women; patients with severe heart or lung diseases or tumor history; patients already taking vitamin d or its similar preparations; participants in other interventional clinical studies (including taking paxlovid); patients with renal insufficiency (egfr<60ml/min/1.73m2); patients considered unsuitable for this study by the investigator；

Number of arms
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

RenJi Hospital

Inclusion age min
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

86

primary outcome
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment

Notes
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

[{"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"}]