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

Primary Purpose

SARS-CoV 2

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Zinc gluconate

25-OH cholecalciferol

About this trial

This is an interventional treatment trial for SARS-CoV 2 focused on measuring Survival, Covid-19, Aged subjects, Zinc, 25-OH cholecalciferol

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Institutionalized

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group supplementation

Group usual treatment

Arm Description

Outcomes

Primary Outcome Measures

Survival rate in asymptomatic subjects at inclusion

Secondary Outcome Measures

Survival rate in symptomatic subjects at inclusion

Survival rate in overall subjects

symptomatic subjects and asymptomatic subjects

Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion

Full Information

NCT ID

NCT04351490

First Posted

April 14, 2020

Last Updated

March 8, 2021

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT04351490

Brief Title

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

Acronym

ZnD3-CoVici

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

change study design and funding

Study Start Date

April 2020 (Anticipated)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV 2

Keywords

Survival, Covid-19, Aged subjects, Zinc, 25-OH cholecalciferol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group supplementation

Arm Type

Experimental

Arm Title

Group usual treatment

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc gluconate

Intervention Description

Zinc gluconate capsule 15 mg x 2 per day during 2 months

Intervention Type

Dietary Supplement

Intervention Name(s)

25-OH cholecalciferol

Intervention Description

25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months

Primary Outcome Measure Information:

Title

Survival rate in asymptomatic subjects at inclusion

Time Frame

Two months after inclusion

Secondary Outcome Measure Information:

Title

Survival rate in symptomatic subjects at inclusion

Time Frame

Two months after inclusion

Title

Survival rate in overall subjects

Description

symptomatic subjects and asymptomatic subjects

Time Frame

Two months after inclusion

Title

Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion

Time Frame

Within two months after inclusion

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Institutionalized Exclusion Criteria: Life expectancy < 1 month independently of Covid-19 infection (overall subjects) Known hypercalcemia History of renal lithiasis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David SEGUY, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33757717

Citation

Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.

Results Reference

derived

Learn more about this trial

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

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