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Withdrawn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
Sponsored by
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
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Withdrawn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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
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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