Determining the effect of zinc supplementation on inflammatory activity and blood cell status in patients with COVID-19
Design
This study is a double-blind randomized controlled clinical trial with parallel groups. the randomization of individuals to the intervention or control group will be done with SPSS software.
Settings and conduct
The study will be performed at Shohada Tajrish Hospital in Tehran. The evaluation of variables will be done at the beginning and end of the study by sampling the patient's blood. The intervention group will receive zinc gluconate supplementation for two weeks and the control group will receive the same number of placebo.
Participants/Inclusion and exclusion criteria
We will invite 44 patients with COVID-19 to enter the study based on inclusion and exclusion criteria.
Inclusion criteria:
1. Being 20 to 60 years old
2. Detection of COVID-19 based on PCR test
3. Willingness to participate in the study
4. Do not take antibiotics and vitamin D
5. Not breastfeeding or pregnant
6. No advanced respiratory distress syndrome leading to intubation
7. No history of alcohol and tobacco use
Exclusion criteria:
1. Taking antioxidant supplements while studying
2. Alcohol and tobacco consumption during the study
Intervention groups
Intervention group: Includes 22 patients with COVID-19 who, in addition to their usual treatments, will take 3*30 mg zinc capsules daily for 2 weeks after meals.
Control group: Includes 22 patients with COVID-19 who, in addition to their usual treatments, will take 3 placebo capsules (maltodextrin) daily for 2 weeks after meals. Placebo capsules are exactly the same in appearance, color, smell and shape as zinc capsules.
Main outcome variables
1. Serum C-Reactive Protein level
2. Serum Interleukin-6 level
3. leukocyte count
4. Total Lymphocyte Count
5. Absolute neutrophil count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210204050238N1
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Morteza Khamoushi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
mortezakhamoushi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc supplementation on inflammatory responses and total blood cells counts of patients who infected with COVID-19
Public title
The effect of zinc supplementation on COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 20 to 60 years old
Detection of COVID-19 based on PCR test and ward admission
Willingness to participate in the study
Intravenous daily intake of 8 mg dexamethasone
Exclusion criteria:
Taking antibiotics and vitamin D.
Advanced Respiratory Distress Syndrome leading to intubation or hospitalization in the intensive care unit
History of alcohol and tobacco use
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Each person is assigned a code and this code is entered into Excel software, randomization will be done using rand function of Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physicians and ward nurses are blind about the study group. Patient is blind about the study group. investigator is blind about the study group. data analyzer is blind about the study group. Assignment of patients in treatment and placebo groups is performed by a nurse out of above mentioned groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences
Street address
central headquarters of Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.849
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1 COVI
ICD-10 code description
COVID-19 , virus identified
Primary outcomes
1
Description
Serum C-Reactive Protein level
Timepoint
The first day and the last day of the intervention
Method of measurement
blood analysis
2
Description
Serum Interleukin-6 level
Timepoint
The first day and the last day of the intervention
Method of measurement
Using blood, serum IL-6 value in Picograms per deciliter by Kit
3
Description
blood leukocyte count
Timepoint
The first day and the last day of the intervention
Method of measurement
blood analysis
4
Description
Total Lymphocyte Count
Timepoint
The first day and the last day of the intervention
Method of measurement
blood analysis
5
Description
Absolute neutrophil count
Timepoint
The first day and the last day of the intervention
Method of measurement
blood analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes 22 patients with COVID-19 who, in addition to their usual treatments, will take 3*30 mg zinc capsules daily for 2 weeks (14 days) after meals.
Category
Treatment - Drugs
2
Description
Control group: Includes 22 patients with COVID-19 who, in addition to their usual treatments, will take 3 placebo capsules (maltodextrin) daily for 2 weeks (14 days) after meals. Placebo capsules are exactly the same in appearance, color, smell and shape as zinc capsules.
Vice Chancellor for Research and Technology, Central University Organization, sixth floor, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8163 3685
Fax
Email
vcr@tums.ac.ir
Web page address
http://en.tums.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
ُُSeyed Morteza Seyed khamoushi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Fax
+98 21 8898 4861
Email
mortezakhamoushi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Fax
+98 21 8898 4861
Email
h-imani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ُُSeyed Morteza Seyed khamoushi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Fax
+98 21 8898 4861
Email
mortezakhamoushi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information can be shared two months after the results are published.
When the data will become available and for how long
Two months after the results are published.
To whom data/document is available
Doctors, nurses, and infectious disease specialists
Under which criteria data/document could be used
To evaluate other complementary therapies and compare their effects with existing COVID-19 therapy
From where data/document is obtainable
Send email to mortezakhamoushi@gmail.com
What processes are involved for a request to access data/document
Two months publishing results, send a clear written request by sending an email to mortezakhamoushi@gmail.com. In this case, and finally within one month after receiving the email, the request will be answered.