Back to resultsCalcitriol Supplementation in COVID-19 Patients
Primary Purpose
COVID-19, Vitamin D Deficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Calcitriol
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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:
- 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；
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment group
control group
Arm Description
calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment
COVID-19 routine treatment
Outcomes
Primary Outcome Measures
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
Nucleic acid test of COVID-19
Secondary Outcome Measures
Clinical symptoms changes
fever, cough, sore throat，etc
Laboratory examination changes
Complete Blood Count， inflammatory markers ，cytokines
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05415254
Brief Title
Calcitriol Supplementation in COVID-19 Patients
Official Title
A Randomized Open Label Study to Evaluate Efficacy of Calcitriol Supplementation in COVID-19 Patients With Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 12, 2022 (Anticipated)
Primary Completion Date
August 19, 2022 (Anticipated)
Study Completion Date
September 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
treatment group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment
Arm Title
control group
Arm Type
No Intervention
Arm Description
COVID-19 routine treatment
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Rocaltrol
Intervention Description
Calcitriol supplementation orally
Primary Outcome Measure Information:
Title
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
Description
Nucleic acid test of COVID-19
Time Frame
The 6th day after treatment
Secondary Outcome Measure Information:
Title
Clinical symptoms changes
Description
fever, cough, sore throat，etc
Time Frame
The 6th day after treatment
Title
Laboratory examination changes
Description
Complete Blood Count， inflammatory markers ，cytokines
Time Frame
The 6th day after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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；
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Ma, Dr.
Phone
+86-21-68383083
Email
cherry1996@live.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Feng, Dr.
Phone
+86-21-68383083
Email
wenwenshimei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ma, Dr.
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33714594
Citation
Angelidi AM, Belanger MJ, Lorinsky MK, Karamanis D, Chamorro-Pareja N, Ognibene J, Palaiodimos L, Mantzoros CS. Vitamin D Status Is Associated With In-Hospital Mortality and Mechanical Ventilation: A Cohort of COVID-19 Hospitalized Patients. Mayo Clin Proc. 2021 Apr;96(4):875-886. doi: 10.1016/j.mayocp.2021.01.001. Epub 2021 Jan 9.
Results Reference
background
PubMed Identifier
34160843
Citation
Wang Z, Joshi A, Leopold K, Jackson S, Christensen S, Nayfeh T, Mohammed K, Creo A, Tebben P, Kumar S. Association of vitamin D deficiency with COVID-19 infection severity: Systematic review and meta-analysis. Clin Endocrinol (Oxf). 2022 Mar;96(3):281-287. doi: 10.1111/cen.14540. Epub 2021 Jul 12.
Results Reference
background
PubMed Identifier
34165766
Citation
Pal R, Banerjee M, Bhadada SK, Shetty AJ, Singh B, Vyas A. Vitamin D supplementation and clinical outcomes in COVID-19: a systematic review and meta-analysis. J Endocrinol Invest. 2022 Jan;45(1):53-68. doi: 10.1007/s40618-021-01614-4. Epub 2021 Jun 24.
Results Reference
background
PubMed Identifier
34508882
Citation
Elamir YM, Amir H, Lim S, Rana YP, Lopez CG, Feliciano NV, Omar A, Grist WP, Via MA. A randomized pilot study using calcitriol in hospitalized COVID-19 patients. Bone. 2022 Jan;154:116175. doi: 10.1016/j.bone.2021.116175. Epub 2021 Sep 8.
Results Reference
background
Links:
URL
http://wjahr.com/home/article_abstract/633
Description
Controlling COVID-19 pandemic through hormone calcitriol
Learn more about this trial
Calcitriol Supplementation in COVID-19 Patients
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