NCT05415254

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 10, 2022

Last Update Submit

June 10, 2022

Conditions

COVID-19Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment

    Nucleic acid test of COVID-19

    The 6th day after treatment

Secondary Outcomes (2)

  • Clinical symptoms changes

    The 6th day after treatment

  • Laboratory examination changes

    The 6th day after treatment

Study Arms (2)

treatment group

EXPERIMENTAL

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

Drug: Calcitriol

control group

NO INTERVENTION

COVID-19 routine treatment

Interventions

CalcitriolDRUG

Calcitriol supplementation orally

Also known as: Rocaltrol
treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related 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.

    PMID: 33714594BACKGROUND

  • 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.

    PMID: 34160843BACKGROUND

  • 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.

    PMID: 34165766BACKGROUND

  • 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.

    PMID: 34508882BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Vitamin D Deficiency

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jing Ma, Dr.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ma, Dr.

CONTACT

+86-21-68383083cherry1996@live.cn

Juan Feng, Dr.

CONTACT

+86-21-68383083wenwenshimei@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: treatment group and control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 13, 2022

Study Start

June 12, 2022

Primary Completion

August 19, 2022

Study Completion

September 19, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)