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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
Comments
-