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

SARS-CoV 2 Clinical Trial

— ZnD3-CoVici  

Official title:

Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04351490
• Other study ID #: 2020_30
• Secondary ID: 2020-A00873-36
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: July 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Institutionalized

Exclusion Criteria:

• Life expectancy < 1 month independently of Covid-19 infection (overall subjects)

• Known hypercalcemia

• History of renal lithiasis

Related Conditions & MeSH terms

• SARS-CoV 2

Intervention

Dietary Supplement:
• Zinc gluconate
Zinc gluconate capsule 15 mg x 2 per day during 2 months
• 25-OH cholecalciferol
25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate in asymptomatic subjects at inclusion		Two months after inclusion
Secondary	Survival rate in symptomatic subjects at inclusion		Two months after inclusion
Secondary	Survival rate in overall subjects	symptomatic subjects and asymptomatic subjects	Two months after inclusion
Secondary	Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion		Within two months after inclusion