Back to resultsEffect of Vitamin D on Hospitalized Adults With COVID-19 Infection
Primary Purpose
Covid19
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility 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.
Sites / Locations
- CHU Liège
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test treatment
Placebo treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Vitamin D serum concentration
Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration
Secondary Outcome Measures
Clinical improvement
Ordinal scale for clinical improvement as recommended by WHO
Hospital length of stay.
Hospital length of stay.
Intensive care unit length of stay.
Intensive care unit length of stay.
Supplemental oxygen, non-invasive or invasive ventilation or organ support
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).
Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
Duration of any organ support
Absence of fever
Time until absence of fever for more than 48h without antipyretics.
Time until negative laboratory SARS-CoV-2 test.
Time until negative laboratory SARS-CoV-2 test.
Mortality all causes.
Mortality all causes.
Mortality related to Covid-19.
Mortality related to Covid-19.
Biological markers
Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3
Full Information
NCT ID
NCT04636086
First Posted
November 17, 2020
Last Updated
May 17, 2022
Sponsor
University of Liege
Collaborators
Laboratoires SMB S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04636086
Brief Title
Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection
Official Title
Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
Laboratoires SMB S.A.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
D-Cure
Intervention Description
Vitamin D supplementation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Vitamin D serum concentration
Description
Mean change from screening to end of treatment phase in 25(OH)D3 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
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
Ordinal scale for clinical improvement as recommended by WHO
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
Title
Hospital length of stay.
Description
Hospital length of stay.
Time Frame
at day 15 to 30 after hospital discharge
Title
Intensive care unit length of stay.
Description
Intensive care unit length of stay.
Time Frame
at day 15 to 30 after hospital discharge
Title
Supplemental oxygen, non-invasive or invasive ventilation or organ support
Description
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).
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
Title
Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
Description
Duration of any organ support
Time Frame
at day 15 to 30 after hospital discharge
Title
Absence of fever
Description
Time until absence of fever for more than 48h without antipyretics.
Time Frame
Last day of hospitalization, or at at day 15 to 30 after hospital discharge
Title
Time until negative laboratory SARS-CoV-2 test.
Description
Time until negative laboratory SARS-CoV-2 test.
Time Frame
Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Title
Mortality all causes.
Description
Mortality all causes.
Time Frame
Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Title
Mortality related to Covid-19.
Description
Mortality related to Covid-19.
Time Frame
Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Title
Biological markers
Description
Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHU Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection
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