Clincosm LogoSign in Get a demo

Calcitriol Supplementation in COVID-19 Patients

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05415254
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
3.3
Anticipated Duration (Months)
26.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
treatment group and control grouptreatment group and control group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Open Label Study to Evaluate Efficacy of Calcitriol Supplementation in COVID-19 Patients With Vitamin D Deficiency
Anticipated Study Start Date :
Jun 12, 2022
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Sep 19, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Clinical symptoms changes [The 6th day after treatment]

      fever, cough, sore throat，etc

    2. Laboratory examination changes [The 6th day after treatment]

      Complete Blood Count， inflammatory markers ，cytokines

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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；

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05415254
    Other Study ID Numbers:
    • IIT-2022-0072
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Vitamin D Deficiency
    Calcitriol

    Study Results

    No Results Posted as of Jun 13, 2022