Comparison of the effects of vitamin A supplementation with standard therapies in the treatment of outpatients with COVID-19
Design
A control trial with a control group, with a parallel groups, double-blind, randomized, phase 3 group on 140 patients that will be randomized using block method and Random Allocation software.
Settings and conduct
This study is performed in Amir Al-Momenin Hospital in Arak. Blinding is a double-blind type and will be done using a placebo. In this way, patients will be blind to the clinical caregiver, outcome assessor, and data analyzer, recognizing groups based solely on the letters A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having clinical signs and test results confirming COVID-19; CRP level higher than 0.3 mg per liter; ESR higher than 22 mm per hour for women and 29 mm per hour for men.
Exclusion criteria: Having any autoimmune disease (lupus, MS, etc.); Suffering from diseases that interfere with the absorption of vitamin A; patients with severe renal insufficiency and dialysis; lactation and pregnancy
Intervention groups
Control group: they receive only the national standard treatment and a placebo drug similar to the main drug. Intervention group: In addition to the standard treatment recommended in the national protocol, they will receive 25,000 international units of vitamin A orally per day for 10 days.
Comparing the effect of standard treatment with and without vitamin A supplementation in improving the clinical symptoms of outpatients with COVID-19
Public title
The effect of vitamin A supplementation in outpatients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having clinical signs and test results that confirm COVID-19
CRP level higher than 0.3 mg per liter
Having an ESR higher than 22 mm per hour for women and 29 mm per hour for men
Exclusion criteria:
Having any autoimmune disease (lupus, MS, etc.)
Suffering from diseases that interfere with the absorption of vitamin A.
Consumers of vitamin A supplements
Patients with severe renal insufficiency and dialysis
Patients with underlying liver disease
Pregnancy
Lactation
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is performed using block generation method and Random Allocation software.
Random Allocation software provides a table of 140 in which our two groups, groups A and B, are each repeated 70 times randomly to minimize the possibility of biased intervention. Each cell in this table is called a block. There will be one patient in each block and the therapist will refer the patients who meet the inclusion criteria to the pharmacy and the patients will be placed in the random blocks of the above table, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be a double-blind study using placebo. Therefore, in order to blind in this study, patients, laboratory technicians, therapist who will be responsible for the activity of prescribing drugs, receiving samples and completing a questionnaire, as well as the researcher responsible for evaluating the results and statistical analyzer will be blind to patient allocation, and will not know which patient is in the intervention and which patient is in the control group. The main researcher will not be blind to the groups and will prepare the drugs and placebo in two packages A and B and place them in the pharmacy with the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
IR.ARAKMU.REC.1399.162
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Clinical symptoms improvement
Timepoint
Before the intervention and 10 days after the start of the intervention
Method of measurement
Definition of clinical improvement includes normalization of body temperature (≤37.2's,) number of breaths (≤ 24 breaths per minute,) oxygen saturation (> 94% at room temperature) that is stable for at least 24 hours
2
Description
Hospitalization
Timepoint
Ten days after the start of the intervention
Method of measurement
Patients' hospitalization will be recorded using a questionnaire and their follow-up.
3
Description
C-reactive protein
Timepoint
Before the intervention and 10 days after the intervention
Method of measurement
Hemagglutination
4
Description
Erythrocyte Sedimentation Rate
Timepoint
Before the intervention and 10 days after the intervention
Method of measurement
Erythrocyte Sedimentation test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to receiving the national standard treatment, patients will receive oral vitamin A 25,000 international units (Zahravi-Iran) per day for 10 days.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients receive only the national standard treatment with an oral placebo similar to the main drug, once a day for 10 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Mehdi Shokri
Street address
Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
dr_mehdi75@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Shokri
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
dr_mehdi75@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Shokri
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
dr_mehdi75@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Shokri
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Payambar-e-azam Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
dr_mehdi75@yahoo.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
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data
When the data will become available and for how long
from 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Therefore, obtaining permission for all processes is free
From where data/document is obtainable
Arak University of Medical Sciences
What processes are involved for a request to access data/document