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Recruitment Status : Withdrawn (change study design and funding)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

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: COVID-19 (Coronavirus Disease 2019) Vitamin D

Drug Information available for: Cholecalciferol Zinc gluconate Zinc, elemental

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

Survival rate in asymptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections	RNA Virus Infections Lung Diseases Respiratory Tract Diseases Cholecalciferol Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Bone Density Conservation Agents

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