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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351490
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE April 14, 2020
First Posted Date  ICMJE April 17, 2020
Last Update Posted Date April 21, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
Survival rate in asymptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Survival rate in symptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]
  • Survival rate in overall subjects [ Time Frame: Two months after inclusion ]
    symptomatic subjects and asymptomatic subjects
  • Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion [ Time Frame: Within two months after inclusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19
Official Title  ICMJE Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group supplementation
    Interventions:
    • Dietary Supplement: Zinc gluconate
    • Dietary Supplement: 25-OH cholecalciferol
  • No Intervention: Group usual treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
3140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Institutionalized

Exclusion Criteria:

  • Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
  • Known hypercalcemia
  • History of renal lithiasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David SEGUY, MD,PhD 0320444850 ext +33 david.seguy@chru-lille.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04351490
Other Study ID Numbers  ICMJE 2020_30
2020-A00873-36 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David SEGUY, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP