Calcitriol Supplementation in COVID-19 Patients

NCT ID: NCT05415254

Last Updated: 2022-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-12

Study Completion Date

2022-09-19

Brief Summary

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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

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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.

Conditions

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COVID-19 Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

treatment group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

Calcitriol supplementation orally

control group

COVID-19 routine treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Calcitriol

Calcitriol supplementation orally

Intervention Type DRUG

Other Intervention Names

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Rocaltrol

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Ma, Dr.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Jing Ma, Dr.

Role: CONTACT

+86-21-68383083

Juan Feng, Dr.

Role: CONTACT

+86-21-68383083

References

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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.

Reference Type BACKGROUND
PMID: 33714594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34160843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34165766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34508882 (View on PubMed)

Related Links

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http://wjahr.com/home/article_abstract/633

Controlling COVID-19 pandemic through hormone calcitriol

Other Identifiers

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IIT-2022-0072

Identifier Type: -

Identifier Source: org_study_id

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