Determining the effect of supplementation on improving the clinical and experimental status of patients with the disease Evaluation of the effect of adjuvant supplementation on the length of hospital stay in patients with the disease Evaluation of the effect of supplementation or on the severity of symptoms in patients with the disease Evaluating the effect of McNell help on mortality in patients with the disease Evaluation of the relationship between plasma levels and the severity of clinical and experimental findings in patients with some form
Design
A randomized, double-blind, randomized controlled clinical trial on 140 patients. A table of random numbers is used for randomization
Settings and conduct
The intervention will be performed in two groups as follows: Group one: Consumption of 50 mg zinc supplement daily Group two: placebo Blood samples are taken before and after the intervention This intervention will be carried out in Mashhad-Iran Blinding will be done for individuals and researchers
Participants/Inclusion and exclusion criteria
Exclusion criteria: Participate in another randomized trial study Inclusion criteria: Age 18 to 65 years Diagnosis of Qovid 19 infection based on the approval of a specialist
Intervention groups
Intervention group: Daily consumption of 50 mg zinc supplement Control group: receiving place
Main outcome variables
death; Inflammatory factors; Duration of hospitalization; Severity of symptoms; Clinical and laboratory status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053046N1
Registration date:2021-11-25, 1400/09/04
Registration timing:registered_while_recruiting
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Zahra Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 8041
Email address
lotfiz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-17, 1400/08/26
Expected recruitment end date
2022-08-17, 1401/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation in diagnosed cases of 2019 Novel Coronavirus (SARS-CoV-2); a randomized clinical trial
Public title
Effect of zinc supplementationin diagnosed cases of 2019 novel coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 infection is subject to the approval of a specialist
Age 18 to 65 years
Exclusion criteria:
addict
Allergy to zinc
Pregnancy and lactation
Occurrence of special medical conditions
History of AIDS and chronic lung disease
History of corticosteroids and chemotherapy drugs in the past month
Use of drugs that affect metabolism
Use multivitamin supplements that are more than 10 mg per day
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
2
Surface crp surface relative to copper to zinc surface relative to neutrophil to lymphocyte LDH level
Randomization (investigator's opinion)
Randomized
Randomization description
In order to create a balance in the number of samples assigned to each of the groups studied, individuals are randomly divided into two groups by blocking method: Accordingly, because we have two groups, the allocation is done in the form of AB, BA and after reaching To the desired volume, it is randomly determined whether group A or B is the intervention group or placebo.Each patient is randomly assigned to one of the two intervention or control groups. Randomization is done in such a way that the type of treatment (intervention group or control group) is placed in closed envelopes and then one envelope is randomly assigned to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind study: In this type of study, both participants and researchers are not initially aware that the individual is in the control or intervention group, and neither participants nor researchers are aware of the allocation of medication or placebo to patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.MUMS.REC.1400.111
Health conditions studied
1
Description of health condition studied
Covid_19
ICD-10 code
U07.1
ICD-10 code description
Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations
Primary outcomes
1
Description
Level CRP
Timepoint
Measurement of reaction level _ thirty before the intervention and 14 days after starting zinc supplementation
Method of measurement
Enzyme-dependent immunosorbent assay kit
Secondary outcomes
1
Description
Level of neutrophil to lymphocyte ratio
Timepoint
Measurement of neutrophil to lymphocyte ratio level before intervention and 14 days after zinc supplementation
Method of measurement
Microscopic counting
Intervention groups
1
Description
Intervention group:50 mg zinc tablets as a single dose made by Alhawi company for 14 days daily with lunch
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets, 14 days, with lunch, slaughtered in the Department of Pharmacology, Mashhad University of Medical Sciences
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Seyedeh Zahra Lotfi
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Lotfiz@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Lotfi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Lotfiz@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Lotfi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Lotfiz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omolbanin hajhoseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Azadi Square, Campus of Mashhad University of Medical Sciences, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
91779485
Phone
+98 51 3800 2420
Email
Hajhoseinio981@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patients' identities will be kept confidential and will not be published anywhere
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study protocol will be published and made available to researchers after the end of the study.
When the data will become available and for how long
Start of access protocol period to articles from 1401
To whom data/document is available
Academic and scientific researchers can apply to receive
Under which criteria data/document could be used
Scientific articles of this project can be used by researchers
From where data/document is obtainable
To receive articles, please contact the following email: lotfiz@mums.ac.ir
What processes are involved for a request to access data/document
If articles and protocols are published, they can receive them via email