Protocol summary

Study aim
Given the anti-inflammatory role of vitamin A, the aim of the present study was to investigate the effect of vitamin A supplementation on the symptoms of acute respiratory syndrome in patients with COVID-19.
Design
Phase 3 clinical trial with control group on 120 patients, without blinding, randomized by random numbers table.
Settings and conduct
Clinical trials will be conducted at Firoozgar Medical Training Center affiliated to Iran University of Medical Sciences in Tehran on patients admitted with COVID-19. Patients are treated in two groups: intervention and control. The study will be performed at the beginning of hospitalization. At the end of the study, the information of two groups of patients will be blindly provided to the statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 80-18 years; Desire for participate to the project. Non-inclusion criteria: Severe liver and biliary disease and known pancreatitis; History of vitamin A supplementation last month; Pregnancy; Breastfeeding.
Intervention groups
Individuals in the intervention group receive 50,000 IU of vitamin A through injection, daily, for 10 days in addition to routine treatment, and the control group receives only routine treatment.
Main outcome variables
Weaning time from ventilator

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200405046951N1
Registration date: 2020-06-11, 1399/03/22
Registration timing: registered_while_recruiting

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
Registrant information
Name
Azadeh Mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8603 6080
Email address
mottaghi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation with vitamin A on improvement of symptoms of acute respiratory syndrome in patients with COVID-19: A randomized clinical trial
Public title
Vitamin A and COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-80 years old The same treatment protocol Desire to participate in project
Exclusion criteria:
Severe liver and biliary disease and known pancreatitis History of vitamin A supplementation last month Pregnancy Lactation
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers, patients will be assigned to intervention and control groups, and this process will continue until two groups of 60 people are formed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Sciences
Street address
Research Vice Chancellor of Iran University of Medical Sciences, Next to blood transfusion organization, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.IUMS.REC.1399.204

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weaning time of ventilator
Timepoint
Before and after of intervention
Method of measurement
time assessment

Secondary outcomes

1

Description
Rapid shallow breathing index (RSBI)
Timepoint
before and after intervention
Method of measurement
ventilator

2

Description
Pao2/Fio2 ratio
Timepoint
before and after intervention
Method of measurement
ventilator

3

Description
Fraction of inspired oxygen (FiO2)
Timepoint
before and after intervention
Method of measurement
ventilator

4

Description
oxygen saturation
Timepoint
before and after intervention
Method of measurement
ventilator

Intervention groups

1

Description
Intervention group: receiving Vitamin 50000 IU through injection
Category
Treatment - Drugs

2

Description
Control group: Routine care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Azadeh Mottaghi
Street address
Behafarin aveue, Karimkhan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8603 6080
Email
mottaghi.azadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Amir Abbas Motevalian
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8603 6080
Email
mottaghi.azadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Mottaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8603 6080
Email
mottaghi.azadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Mottaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8603 6080
Email
mottaghi.azadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Mottaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8603 6080
Email
mottaghi.azadeh@gmail.com

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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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