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Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04636086
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
Laboratoires SMB S.A.
Information provided by (Responsible Party):
Anne-Françoise Rousseau, University of Liege

Brief Summary:
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Cholecalciferol Other: Placebo Phase 4

Detailed Description:

Phase IV, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.

Patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period.

A total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Test treatment
Test Treatment: Ampoule for enteral use containing 25,000 IU/mL of cholecalciferol taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36.
Drug: Cholecalciferol
Vitamin D supplementation
Other Name: D-Cure

Placebo Comparator: Placebo treatment
Placebo Treatment: Ampoule of placebo for enteral use containing excipient only taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36.
Other: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Vitamin D serum concentration [ Time Frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge ]
    Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge ]
    Ordinal scale for clinical improvement as recommended by WHO

  2. Hospital length of stay. [ Time Frame: at day 15 to 30 after hospital discharge ]
    Hospital length of stay.

  3. Intensive care unit length of stay. [ Time Frame: at day 15 to 30 after hospital discharge ]
    Intensive care unit length of stay.

  4. Supplemental oxygen, non-invasive or invasive ventilation or organ support [ Time Frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge ]
    Number of patients requiring supplemental oxygen, non-invasive ventilation or high flow oxygen devices, invasive mechanical ventilation or additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation).

  5. Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support [ Time Frame: at day 15 to 30 after hospital discharge ]
    Duration of any organ support

  6. Absence of fever [ Time Frame: Last day of hospitalization, or at at day 15 to 30 after hospital discharge ]
    Time until absence of fever for more than 48h without antipyretics.

  7. Time until negative laboratory SARS-CoV-2 test. [ Time Frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge ]
    Time until negative laboratory SARS-CoV-2 test.

  8. Mortality all causes. [ Time Frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge ]
    Mortality all causes.

  9. Mortality related to Covid-19. [ Time Frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge ]
    Mortality related to Covid-19.

  10. Biological markers [ Time Frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge ]
    Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female over 18 years old (18 years inclusive).
  • Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization.
  • Expected to survive for at least 96 hours after study entry.
  • If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence).
  • Subject or legally authorized representative understands and agrees to comply with planned study procedures.
  • Subject or legally authorized representative provides informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  • Women currently pregnant or breast-feeding.
  • Patients presenting acute impairment of renal function or nephrolithiasis.
  • Patients presenting hypercalcaemia and/or hypercalciuria
  • Patients presenting pseudohypoparathyroidism
  • Use of any vitamin D supplementation alone or in association at screening visit;
  • Use of any prohibited medication as detailed in the concomitant medication section
  • Patients with any sensitivity or allergy to any of the products used within this clinical trial.
  • Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636086


Contacts
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Contact: Anne-Françoise Rousseau, MD, PhD +3243667495 afrousseau@chuliege.be

Locations
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Belgium
CHU Liège Recruiting
Liège, Belgium, 4000
Contact: Anne-Françoise Rousseau    043667495    afrousseau@chuliege.be   
Sponsors and Collaborators
University of Liege
Laboratoires SMB S.A.
Publications:

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Responsible Party: Anne-Françoise Rousseau, Head of Clinic, University of Liege
ClinicalTrials.gov Identifier: NCT04636086    
Other Study ID Numbers: D-COVID
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents