Clinical trial NCT04636086: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Laboratoires SMB S.A.
First posted: 2020-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vitamin D serum concentration
timeFrame: 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 outcomes:
measure: Clinical improvement
timeFrame: 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
measure: Hospital length of stay.
timeFrame: at day 15 to 30 after hospital discharge
measure: Intensive care unit length of stay.
timeFrame: at day 15 to 30 after hospital discharge
measure: Supplemental oxygen, non-invasive or invasive ventilation or organ support
timeFrame: 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
measure: Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
timeFrame: at day 15 to 30 after hospital discharge
measure: Absence of fever
timeFrame: Last day of hospitalization, or at at day 15 to 30 after hospital discharge
measure: Time until negative laboratory SARS-CoV-2 test.
timeFrame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
measure: Mortality all causes.
timeFrame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
measure: Mortality related to Covid-19.
timeFrame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
measure: Biological markers
timeFrame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
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