Calcitriol Supplementation in COVID-19 Patients

Not Applicable

• Conditions: COVID-19; Vitamin D Deficiency
• Interventions: Drug: Calcitriol

• Registration Number: NCT05415254
• Lead Sponsor: RenJi Hospital

Brief Summary

This is a randomized, open label study to evaluate the efficacy and safety of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

Detailed Description

This is a randomized, open label study to evaluate the efficacy （clinical and laboratory change）and safety （serum calcium） of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Last Update Submitted: 2022-06-10
• Study Start: 2022-06-12
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13
• Primary Completion: 2022-08-19
• Study Completion: 2022-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Hospitalized symptomatic COVID-19 patients;
2. COVID-19 nucleic acid Ct value < 28 (both orf1ab gene Ct value and N gene Ct value < 28);
3. Vitamin D deficiency: 25OHD ≤ 20ng/ml;
4. Age: 18-70 years old;

Exclusion Criteria

1. Asymptomatic COVID-19 patients ；
2. Hypercalcemia;
3. History of primary hyperparathyroidism;
4. History of triple hyperparathyroidism;
5. Patients who are allergic to calcitriol;
6. Pregnant or lactating women;
7. Patients with severe heart or lung diseases or tumor history;
8. Patients already taking vitamin D or its similar preparations;
9. Participants in other interventional clinical studies (including taking paxlovid);
10. Patients with renal insufficiency (eGFR<60ml/min/1.73m2);
11. Patients considered unsuitable for this study by the investigator；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Calcitriol	calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment

Primary Outcome Measures

Name	Time	Method
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment	The 6th day after treatment	Nucleic acid test of COVID-19

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms changes	The 6th day after treatment	fever, cough, sore throat，etc
Laboratory examination changes	The 6th day after treatment	Complete Blood Count， inflammatory markers ，cytokines

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China