Clinical trial NCT05415254: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Vitamin D Deficiency
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment group and control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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；

Primary outcomes:
measure: The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
timeFrame: The 6th day after treatment
Secondary outcomes:
measure: Clinical symptoms changes
timeFrame: The 6th day after treatment
measure: Laboratory examination changes
timeFrame: The 6th day after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jing Ma, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.