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Withdrawn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
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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) |
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 |

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 |
- 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 ]

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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 |
Inclusion Criteria:
- Institutionalized
Exclusion Criteria:
- Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
- Known hypercalcemia
- History of renal lithiasis

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
Principal Investigator: | David SEGUY, MD,PhD | University Hospital, Lille |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Survival Covid-19 Aged subjects Zinc 25-OH cholecalciferol |
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 |