History
# Registration date Revision Id
2 2020-09-29, 1399/07/08 152870
1 2020-03-29, 1399/01/10 127213
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  • General information

    empty
    according to PIs recommendation the respiratory sign were reported as clinical response.
    empty
    با توجه به توصیه مجریان طرح و متخصصین بالینی علائم تنفسی بصورت پاسخ بالینی محاسبه شده و درج خواهد شد
  • Primary outcomes

    #1
    hospitalization duration
    clinical response
    مدت زمان بستری در بیمارستان
    پاسخ به درمان
  • Secondary outcomes

    #1
    repiratory signs
    hospitalization period
    علائم تنفسی
    مدت زمان بستری در بیمارستان
    daily
    at the end of study
    روزانه
    در انتهای مطالعه
    clinical evaluation and questionnaire
    medical record review
    معیانه بالنی و تکمیل پرسشنامه
    بررسی پرونده
    #2
    empty
    mechanical ventilation need
    empty
    نیاز به ونتیلاتور
    empty
    During the study
    empty
    در طول مطالعه
    empty
    medical record review
    empty
    بررسی پرونده پزشکی

Protocol summary

Study aim
Determination of the effect of vitamin A on respiratory sign and hospitalization duration inn patients with covid19
Design
two arm, parallel group randomized controlled trial
Settings and conduct
This study will be conducted in Imam Reza hospital, affiliated with Tabriz University of medical sciences. based on inclusion criteria 30 patients will be selected and respiratory signs and saturation rate will be recorded at the first day of hospitalization. then he patients will randomly divided to two groups of 15 patients. in vitamin A group, the patients will receive 50000 dose of vitamin A along with routine treatments and in the control group, The patients will receive only the routine treatments. after two weeks the respiratory sing, saturation rate and hospitalization days will be recorded
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirmed diagnosis of COVID19 with RT-PCR; hospitalized patients; ventilator independent patients; Exclusion criteria: being pregnant; lactating mothers; not consent to participate in the study; using high-dose vitamin A in last month.
Intervention groups
Vitamin A group will be include 15 patients with COVID19 that will be treated with vitamin A 50000 along with routine treatment for two weeks Control group will also include 15 patients with COVID19 that will be treated with only routine treatment for two weeks
Main outcome variables
Hospitalization duration respiratory signs

General information

Reason for update
according to PIs recommendation the respiratory sign were reported as clinical response.
Acronym
IRCT registration information
IRCT registration number: IRCT20170117032004N3
Registration date: 2020-03-29, 1399/01/10
Registration timing: prospective

Last update: 2020-09-29, 1399/07/08
Update count: 1
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Zeinab Nikniaz
Name of organization / entity
Liver and gastrointestinal disease research center, Tabriz University of medical sciences-Tabriz_Ir
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 7473
Email address
nikniazz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of vitamin A on respiratory signs and hospitalization in patients with COVID-19
Public title
Effect of vitamin A in patients with COVID19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
confirmed diagnosis of COVID19 with RT-PCR hospitalized patients ventilator independent patients
Exclusion criteria:
being pregnant, lactating mothers, not consent to participate in the study using high-dose vitamin A in last month
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
simple random allocation using computer by a person who is not one of researcher of the study and based on the numbers allocated to each patients.
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
Ethics committee of Tabriz University of medical sciences
Street address
Tabriz University of medical sciences, Daneshgah Ave.Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.TBZMED.REC.1398.1305

Health conditions studied

1

Description of health condition studied
U07.1
ICD-10 code
07.1
ICD-10 code description
Confirmed cases

Primary outcomes

1

Description
clinical response
Timepoint
until discharge from hospital
Method of measurement
Questionnaire

Secondary outcomes

1

Description
hospitalization period
Timepoint
at the end of study
Method of measurement
medical record review

2

Description
mechanical ventilation need
Timepoint
During the study
Method of measurement
medical record review

Intervention groups

1

Description
Intervention group: 50000 Vitamin A daily for two weeks
Category
Treatment - Other

2

Description
Control group: common treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Zeinab Nikniaz
Street address
Imam Reza Hospital, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Sameiee
Street address
Tabriz University of medical sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
lgdrc2005@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Nikniaz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Liver and gastrointestinal diseases research center, Imam Reza Hospital, Tabriz University of medical sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 1688
Email
znikniaz@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ةeinab Niknaiz
Position
Assistant Proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41133351688
Fax
Email
znikniaz@hitmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Nikniaz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Tabriz University of medical sciences, Tabriz_Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 7473
Fax
Email
nikniazz@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
Title and more details about the data/document
Not decided
When the data will become available and for how long
Not decided
To whom data/document is available
Not decided
Under which criteria data/document could be used
Not decided
From where data/document is obtainable
Not decided
What processes are involved for a request to access data/document
Not decided
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