The Effect of Vitamin D Supplementation on COVID-19 Recovery

NCT04883203 | Completed Phase 3 DMC

• 1 other identifier: VITD COVIDMonastir
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global public health emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was 20 days (IQR 16-28) What is the role of vitamin D supplementation on the recovery time of asymptomatic and pauci-symptomatic COVID-19 subjects? the intervention group will have vitamin D supplementation (200,000 IU / 1 ml of Cholecalciferol (1 ml) Oral form). Control group will have a placebo treatment (physiological saline). the negative RT-PCR date will be compared in the two groups

Conditions

Covid19

Keywords

COVID 19; Vitamin D; Recovery

Outcome Measures

Primary Outcomes (1)

• Vitamin D supplementation and recovery delay in COVID-19 patients

  Delay between the first positive RT-PCR and the second negative RT-PCR

  3 months

Study Arms (2)

VITD

ACTIVE COMPARATOR

A single vial of Cholecalciferol (1 ml) (200,000 IU / 1 m), Oral form,

Drug: Vit-D 0.2 MG/ML Oral Solution [Calcidol]

Placebo

PLACEBO COMPARATOR

A single vial of physiological salin Oral form

Drug: Physiological Irrigating Solution

Interventions

Vit-D 0.2 MG/ML Oral Solution [Calcidol] DRUG

ARM 1 : Cholecalciferol 200,000 IU / 1 mL .

VITD

Physiological Irrigating Solution DRUG

ARM 2 : placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with COVID 19 and having a positive RT-PCR at control in
• days from confirmation of infection for asymptomatic subjects and
• days after the disappearance of symptoms for pauci-symptomatic subjects

You may not qualify if:

• None

Sponsors & Collaborators

• University of Monastir: lead
• Loussaief Chawki: collaborator
• Nissaf Ben Alaya: collaborator
• Cyrine Ben Nasrallah: collaborator
• Manel Ben Belgacem: collaborator
• Hela Abroug: collaborator
• Imen Zemni: collaborator
• Manel Ben fredj: collaborator
• Wafa Dhouib: collaborator

Study Sites (1)

Asma Sriha Belguit

Monastir, 5000, Tunisia

Location

Related Publications (1)

• Abroug H, Maatouk A, Bennasrallah C, Dhouib W, Ben Fredj M, Zemni I, Kacem M, Mhalla S, Nouira S, Ben Belgacem M, Nasri A, Klii R, Loussaief C, Ben Alya N, Bouanene I, Belguith Sriha A. Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial. Trials. 2023 Feb 20;24(1):123. doi: 10.1186/s13063-023-07114-5.

  PMID: 36803273 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Solutions; Ergocalciferols; Plasmalyte A

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the intervention group will have vitamin D supplementation (200,000 IU / 1 mL of Cholecalciferol (1 ml) Oral form). Control group will have a placebo treatment (physiological saline).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor preventive medicine and epidemiology

Model Details: A randomized clinical trial with 2 parallel arms and participant masking

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 12, 2021
• Study Start: April 22, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

TU (1)