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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liege
• Collaborator: Laboratoires SMB S.A.
• Treatments: Cholecalciferol

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.