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

University of Liege

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Other: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04636086

D-COVID

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Test treatment

Experimental group

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.

Treatment:

Drug: Cholecalciferol

Placebo treatment

Placebo Comparator group

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.

Treatment:

Other: Placebo