Calcitriol Supplementation in COVID-19 Patients

June 10, 2022 updated by: RenJi Hospital

A Randomized Open Label Study to Evaluate Efficacy of Calcitriol Supplementation in COVID-19 Patients With Vitamin D Deficiency

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment
Drug: Calcitriol
Calcitriol supplementation orally
Other Names:
  • Rocaltrol
No Intervention: control group
COVID-19 routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
Time Frame: The 6th day after treatment
Nucleic acid test of COVID-19
The 6th day after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms changes
Time Frame: The 6th day after treatment
fever, cough, sore throat，etc
The 6th day after treatment
Laboratory examination changes
Time Frame: The 6th day after treatment
Complete Blood Count， inflammatory markers ，cytokines
The 6th day after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Jing Ma, Dr., Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 12, 2022

Primary Completion (Anticipated)

August 19, 2022

Study Completion (Anticipated)

September 19, 2022

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2022-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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