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Calcitriol Supplementation in COVID-19 Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05415254
Enrollment
86
Registered
2022-06-13
Start date
2022-06-12
Completion date
2022-09-19
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Vitamin D Deficiency

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.

Interventions

DRUGCalcitriol

Calcitriol supplementation orally

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

treatment group and control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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；

Design outcomes

Primary

MeasureTime frameDescription
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatmentThe 6th day after treatmentNucleic acid test of COVID-19

Secondary

MeasureTime frameDescription
Clinical symptoms changesThe 6th day after treatmentfever, cough, sore throat，etc
Laboratory examination changesThe 6th day after treatmentComplete Blood Count， inflammatory markers ，cytokines

Countries

China

Contacts

Primary ContactJing Ma, Dr.
cherry1996@live.cn+86-21-68383083
Backup ContactJuan Feng, Dr.
wenwenshimei@163.com+86-21-68383083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026