The aim of this study was to assist with desferral drug and vitamin C in reducing iron overload caused by COVID-19 viral infection.
Design
In this study, the intervention, which is done as a randomized clinical trial, selected 78 patients with covid 19 virus who were randomly assigned to two groups with the treatment of desferal supplement with vitamin c and without the treatment of desferal and vitamin C. will be considered. C-reactive protein (CRP) ferritin levels were compared between the two groups using chi-square and Fisher tests and the significance level was 0.05.
Settings and conduct
People with COVID 19 are referred to the Corona ward in Shohada Tajrish Hospital and are treated with desferal supplement along with vitamin C.
Participants/Inclusion and exclusion criteria
The entry criteria for COVID 19 viral infection are high serum ferritin levels and an increase in inflammatory factors in the blood, and the criteria for leaving the study include patients with renal insufficiency or the use of desferal contraceptives.
Intervention groups
Interfering with the treatment of desferal deodorant Baduz 20 to 60 mg per kilogram of body weight with 100 mg of vitamin C and then serum ferritin and factor (C-reactive protein (CRP) which was initially taken from the patient again On the third day after the intervention, it is measured and in the patient control group, do not receive desferal supplement medication, and then at the end, the study of these two groups in terms of ferritin and CRP are compared.
Main outcome variables
The effect of desferral supplement with vitamin C on blood ferritin levels in covid 19 patients
Effect of desferal supplement with vitamin C on C-reactive protein content in patients with covid 19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042444N3
Registration date:2020-07-04, 1399/04/14
Registration timing:registered_while_recruiting
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
faranak behnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
faranak.behnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Considering the administration of Desferral supplementary and Vitamin C on the ferritin levels of Quid 19 patients
Public title
Considering the administration of Desferral supplementary and Vitamin C on the ferritin levels of Quid 19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Get infected with a viral infection COVID-19
High serum ferritin levels
Increased inflammatory factor in the blood
Exclusion criteria:
Patients with renal insufficiency
Consumption of desferal supplementary in them is contraindicated
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, based on the table of random numbers, first the number of samples is entered using a computer and each two-digit code is assigned. The researcher randomly selects a point in the Weston line. This table selects a point if the desired number is smaller than the sample size. Work continues until the sample size is complete
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, desferal supplement medication is taken by nurse
. Here, nurse knows the type of complementary medicine.
So the researcher is blind here
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behesti University of Medical Sciences
Street address
Yaman Ave,Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.256
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
U07.1 COVID posetive
Primary outcomes
1
Description
CRP rate
Timepoint
Before the start of the intervention and the third day after the intervention
Method of measurement
Based on serum surface measurement
2
Description
CRP rate
Timepoint
Before the start of the intervention and the third day after the intervention
Method of measurement
Based on serum surface measurement
Secondary outcomes
empty
Intervention groups
1
Description
In this study, randomly placed in a group of patients with desferal supplementation at a dose of 20 to 60 mg by weight over 8 to 12 hours, along with 100 mg of vitamin C ampoules at the time of hospitalization in the corona section, followed by ferritin and CRP by The patient's blood test is checked to compare their differences with before the intervention
Category
Treatment - Drugs
2
Description
In the control group, desferal supplementation is not given at a dose of 20 to 60 mg per kg body weight with 100 mg of vitamin C ampoules, and ferritin and CRP tests are sent to the patient. They are also compared
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shphada Tajrish Hospital
Full name of responsible person
Faranak Behnaz
Street address
Shohada Hospital,Tajrish SQ ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Asadi
Street address
Yaman AVE, Velenjak
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 2243 2572
Email
nahidasadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital, Tajrish SQ, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ebrahim Sadeghzadeh Sadat
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital,Tajrish SQ
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
sadat13584@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shohada Hospital,Tajrish SQ
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
faranak.behnaz@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
Only part of the data, such as information about the main consequence or the like, can be shared.
When the data will become available and for how long
Start of access period from 1400
To whom data/document is available
Only for researchers in academic and scientific institutions