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

NCT04351490 | Withdrawn

• 2 other identifiers: 2020_302020-A00873-36
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SARS-CoV 2

Keywords

Survival; Covid-19; Aged subjects; Zinc; 25-OH cholecalciferol

Outcome Measures

Primary Outcomes (1)

• Survival rate in asymptomatic subjects at inclusion

  Two months after inclusion

Secondary Outcomes (3)

• Survival rate in symptomatic subjects at inclusion

  Two months after inclusion

• Survival rate in overall subjects

  Two months after inclusion

• Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion

  Within two months after inclusion

Study Arms (2)

Group supplementation

EXPERIMENTAL

Dietary Supplement: Zinc gluconate; Dietary Supplement: 25-OH cholecalciferol

Group usual treatment

NO INTERVENTION

Interventions

Zinc gluconate DIETARY_SUPPLEMENT

Zinc gluconate capsule 15 mg x 2 per day during 2 months

Group supplementation

25-OH cholecalciferol DIETARY_SUPPLEMENT

25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months

Group supplementation

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Institutionalized

You may not qualify if:

• Life expectancy \< 1 month independently of Covid-19 infection (overall subjects)
• Known hypercalcemia
• History of renal lithiasis

Sponsors & Collaborators

• University Hospital, Lille: lead

Related Publications (1)

• 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. No abstract available.

  PMID: 33757717 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David SEGUY, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 11, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share