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 : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 21, 2020
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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|
- Survival rate in asymptomatic subjects at inclusion [ Time Frame: Two months after inclusion ]
- 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 ]
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
|Contact: David SEGUY, MD,PhD||0320444850 ext +firstname.lastname@example.org|
|Principal Investigator:||David SEGUY, MD,PhD||University Hospital, Lille|