Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19 (ZnD3-CoVici)

March 8, 2021 updated by: University Hospital, Lille

Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19

Mortality from Covid-19 increases with age, reaching 14.8% from the age of 80. The severity of the infection is linked to the acute respiratory distress syndrome (ARDS) which requires intensive care. ARDS is the consequence of the reactional inflammatory storm that damages the lungs.

Aged subjects are particularly prone to zinc and vitamin D deficiency. These two micronutrients are able to modulate the immune response by reducing the inflammatory storm.

The hypothesis is that supplementation with zinc and vitamin D would reduce the inflammatory reaction which worsens ARDS and leads to the death of subjects infected with Covid-19.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Institutionalized

Exclusion Criteria:

  • Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
  • Known hypercalcemia
  • History of renal lithiasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group supplementation
Dietary supplement: Zinc gluconate
Zinc gluconate capsule 15 mg x 2 per day during 2 months
Dietary supplement: 25-OH cholecalciferol
25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months
NO_INTERVENTION: Group usual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate in asymptomatic subjects at inclusion
Time Frame: Two months after inclusion
Two months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate in symptomatic subjects at inclusion
Time Frame: Two months after inclusion
Two months after inclusion
Survival rate in overall subjects
Time Frame: Two months after inclusion
symptomatic subjects and asymptomatic subjects
Two months after inclusion
Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion
Time Frame: Within two months after inclusion
Within two months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David SEGUY, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (ACTUAL)

April 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_30
  • 2020-A00873-36 (OTHER: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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