SARS-CoV 2ZnD3-CoViciNCT04351490
Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19
A study testing Zinc gluconate and 25-OH cholecalciferol in people with SARS-CoV 2, run by University Hospital, Lille.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Zinc gluconate and 25-OH cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Institutionalized
Who cannot join
- Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
- Known hypercalcemia
- History of renal lithiasis
About this study
Official title: Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
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
- Being tested
- Zinc gluconate, 25-OH cholecalciferol
- Keywords
- Survival, Covid-19, Aged subjects, Zinc, 25-OH cholecalciferol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc gluconateDietary supplement
Zinc gluconate capsule 15 mg x 2 per day during 2 months
25-OH cholecalciferolDietary supplement
25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Group supplementation | Experimental | Not described Receives: Dietary Supplement: Zinc gluconate; Dietary Supplement: 25-OH cholecalciferol |
| Group usual treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate in asymptomatic subjects at inclusion
Measured: Two months after inclusion
Secondary outcomes (3)
Survival rate in symptomatic subjects at inclusion
Measured: Two months after inclusion
Survival rate in overall subjects
symptomatic subjects and asymptomatic subjects
Measured: Two months after inclusion
Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion
Measured: Within two months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: change study design and funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David SEGUY, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351490
- Sponsor's protocol ID
- 2020_30
- Other IDs
- 2020-A00873-36
- Acronym
- ZnD3-CoVici
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33757717
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
- ClinicalTrials.gov ID
- NCT04351490
- Acronym / sponsor ID
- ZnD3-CoVici / 2020_30
- Conditions
- SARS-CoV 2
- Keywords
- Survival, Covid-19, Aged subjects, Zinc, 25-OH cholecalciferol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change study design and funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group supplementation | Experimental | Dietary Supplement: Zinc gluconate, Dietary Supplement: 25-OH cholecalciferol |
| Group usual treatment | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Institutionalized
Key exclusion criteria (3 listed)
- Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
- Known hypercalcemia
- History of renal lithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc gluconateZinc gluconate capsule 15 mg x 2 per day during 2 months | Dietary supplement | Group supplementation |
| 25-OH cholecalciferol25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months | Dietary supplement | Group supplementation |
Primary outcome
Survival rate in asymptomatic subjects at inclusion
Time frame: Two months after inclusion
3 secondary outcomes
Survival rate in symptomatic subjects at inclusion
Time frame: Two months after inclusion
Survival rate in overall subjects
Time frame: Two months after inclusion
Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion
Time frame: Within two months after inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 33757717Shakoor 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.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV 2
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David SEGUY, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing Zinc gluconate and 25-OH cholecalciferol in people with SARS-CoV 2, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate in asymptomatic subjects at inclusion (time frame: Two months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.