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

NCT ID: NCT04351490

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group supplementation

Group Type EXPERIMENTAL

Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

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

25-OH cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Group usual treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zinc gluconate

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

Intervention Type DIETARY_SUPPLEMENT

25-OH cholecalciferol

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Institutionalized

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David SEGUY, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33757717 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A00873-36

Identifier Type: OTHER

Identifier Source: secondary_id

2020_30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin D and COVID-19 Management
NCT04385940 COMPLETED PHASE3