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

University of Liege is conducting the clinical trial Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection.

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

It is planned to include 100 participants.

Actual study start date is November 12, 2020. The researchers expect to complete the study by February 28, 2021.

One primary outcome measure is Vitamin D serum concentration, Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration.

 

Among the inclusion criteria are the following:

- 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.

Among the exclusion criteria are:

  • 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.

The location of the study is as follows: https://ichgcp.net/clinical-trials-registry/NCT04636086

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