Calcitriol Supplementation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05415254
• Other study ID #: IIT-2022-0072
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 12, 2022
• Est. completion date: September 19, 2022

Study information

• Verified date: June 2022
• Source: RenJi Hospital
• Contact: Jing Ma, Dr.
• Phone: +86-21-68383083
• Email: cherry1996[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: September 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19
• Vitamin D Deficiency

Intervention

Drug:
• Calcitriol
Calcitriol supplementation orally

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment	Nucleic acid test of COVID-19	The 6th day after treatment
Secondary	Clinical symptoms changes	fever, cough, sore throat,etc	The 6th day after treatment
Secondary	Laboratory examination changes	Complete Blood Count, inflammatory markers ,cytokines	The 6th day after treatment

External Links

•   Controlling COVID-19 pandemic through hormone calcitriol