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Status unknownNCT05415254Updated Jun 13, 2022

Calcitriol Supplementation in COVID-19 Patients

An interventional study of Calcitriol in COVID-19 and Vitamin D Deficiency, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19
  • Vitamin D Deficiency
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 86 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Browse RenJi Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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；
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    treatment group

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

    Drug: Calcitriol

  • No intervention
    control group

    COVID-19 routine treatment

Interventions

  • DrugCalcitriol

    Calcitriol supplementation orally

    Also known as: Rocaltrol

06

What researchers measure

Primary outcomes

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

    Nucleic acid test of COVID-19

    Time frame: The 6th day after treatment

Secondary outcomes

  1. Clinical symptoms changes

    fever, cough, sore throat，etc

    Time frame: The 6th day after treatment

  2. Laboratory examination changes

    Complete Blood Count， inflammatory markers ，cytokines

    Time frame: The 6th day after treatment

07

Study locations

1 site
  • Renji Hospital
    Shanghai, Shanghai Municipality 200127, China
08

References and documents

Publications

  • 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. PubMed 33714594 ↗
  • 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. PubMed 34160843 ↗
  • 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. PubMed 34165766 ↗
  • 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. PubMed 34508882 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2022; primary completion for Aug 2022, 2 months later.

Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 2 months is below that.

Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2022
First posted
Jun 13, 2022
StartEst.
Jun 12, 2022
Primary completionEst.
Aug 19, 2022
CompletionEst.
Sep 19, 2022
Last update
Jun 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05415254
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Jun 13, 2022
Start date
Jun 12, 2022 (estimated)
Primary completion
Aug 19, 2022 (estimated)
Completion
Sep 19, 2022 (estimated)
Last update
Jun 13, 2022

Study contacts

Jing Ma, Dr.
Contact
cherry1996@live.cn
+86-21-68383083
Juan Feng, Dr.
Contact
wenwenshimei@163.com
+86-21-68383083
Jing Ma, Dr.
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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