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

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ClinicalTrials.gov Identifier: NCT04351490
Recruitment Status : Withdrawn (change study design and funding)
First Posted : April 17, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.


Condition or disease Intervention/treatment Phase
SARS-CoV 2 Dietary Supplement: Zinc gluconate Dietary Supplement: 25-OH cholecalciferol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Survival rate in asymptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]

Secondary Outcome Measures :
  1. Survival rate in symptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]
  2. Survival rate in overall subjects [ Time Frame: Two months after inclusion ]
    symptomatic subjects and asymptomatic subjects

  3. Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion [ Time Frame: Within two months after inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Institutionalized

Exclusion Criteria:

  • Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
  • Known hypercalcemia
  • History of renal lithiasis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351490


Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: David SEGUY, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04351490    
Other Study ID Numbers: 2020_30
2020-A00873-36 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Survival
Covid-19
Aged subjects
Zinc
25-OH cholecalciferol
Additional relevant MeSH terms:
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Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
 Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents