Evaluation of the effectiveness of vitamin A on the clinical symptoms of COVID-19 disease, including the duration of fever, cough and shortness of breath, and on laboratory factors such as CPR, white blood cells, and creatinine.
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 2 on 94 patients. The rand function of the Excel software was used for randomization
Settings and conduct
All patients admitted to Kamkar Hospital underwent a three-way blind course and were prescribed vitamin A and placebo.
Participants/Inclusion and exclusion criteria
Admission: Start treatment within the first three days of hospitalization
Failure to enter: Pregnant women and those with high cerebrospinal fluid pressure
Intervention groups
There are two intervention and control groups, which are given to the vitamin A intervention group, and the placebo control group is basically a three-way blind
Main outcome variables
Treatment and prevention of primary and secondary complications of COVID_19 disease, including: pulmonary fibrosis, cerebral edema, renal failure, secondary bacterial infections and mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200314046774N1
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Majid Farhadi fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3662 0845
Email address
majidfarhadifard@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-13, 1399/03/24
Actual recruitment start date
2020-05-04, 1399/02/15
Actual recruitment end date
2020-06-13, 1399/03/24
Trial completion date
2020-06-13, 1399/03/24
Scientific title
Assessment of vitamin A effectiveness on COVID-19 patients and treatment outcomes referred to health centers of Qom province
Public title
treatment of COVID-19 whit vitamin A
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients were hospitalized with covid_19 who were hospitalized for at least the first three days
Exclusion criteria:
Pregnant women
who with high cerebrospinal fluid pressure
People with malnutrition (celiac disease, short bowel syndrome, chronic pancreatitis, and impaired fat and anti-obesity and bariatric surgery)
Age
From 1 year old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
94
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 100 patients with covid 19 will be randomly divided into two groups. The selection of groups will be based on the fact that individuals will be assigned to groups based on block randomization. Block size 4 is considered. So we will have four blocks of four, including AB, AABB, BAAB, ABBA, BABA, BBAA, AB. The selection of each block will also be random and will be done using dice. For example, if the number 3 comes in the dice roll, the BBAA block is considered, so the first two patients are treated with B and the next two patients with A treatment. The dice will be thrown 25 times to complete the allocation of patients to treatment groups. Also, treatment allocation to groups A and B will be based on accident (coin toss).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The statistical physician only had access to medical information, and the nurse, physician, and patient were blind.
On the box of real and placebo drugs, codes were written by a statistician and epidemiologist, and the drugs were given to patients by accident, but the doctor, nurse, and patient were unaware of their contents.
The codes were provided to the physician
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qom University of Medical Sciences
Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations.
Primary outcomes
1
Description
rate of O2 saturation
Timepoint
1-3-5-7-10-14
Method of measurement
PCR, CT scan and clinical symptoms
2
Description
clinical symptoms
Timepoint
1-3-5-7-10-14
Method of measurement
PCR, CT scan and clinical symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: "Consumption of Iranian Oral Vitamin A in the name of Ovigel Company 200,000 units today and repeat it tomorrow and then control the clinical and laboratory symptoms on the first, third, fifth, seventh, fourteenth and fourteenth days. Check the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n need mechanical ventilation to check vitamin A side effects
Category
Treatment - Drugs
2
Description
Control group: receives exactly four in appearance similar to the vitamin A capsule (drug Gul) and the next day the same thing is repeated and then the control of clinical symptoms and Laboratory test on the first, third, fifth, seventh, fourteenth, fourteenth day of the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Kamkar hospital
Full name of responsible person
Majid Farhadifard
Street address
No 10, Alley 2,Avenue 13, Emam Khomeini street, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3718913997
Phone
+98 25 3662 0845
Email
Majidfarhadifard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Kohpayehee
Street address
No 83, Alley 4,Alley 1/1,Safashahr street
City
Qom
Province
Ghoum
Postal code
37169934567
Phone
+98 25 3285 4011
Email
reserch@mail.mcq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Majid Farhadifard
Position
پزشک عمومی
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 10, Alley 13,Avenue Emam Khomeini, Qom,Iran
City
Qom
Province
Ghoum
Postal code
3718913997
Phone
+98 25 3662 0845
Email
majidfarhadifard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Majid Farhadifard
Position
پزشک عمومی
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 10, Alley 13, Emam Khomeini avenue, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3718913997
Phone
+98 25 3662 0845
Email
majidfarhadifard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Majid Farhadifard
Position
پزشک عمومی
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 10, Alley 13, Emam Khomeini avenue, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3718913997
Phone
+98 25 3662 0845
Email
majidfarhadifard@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data is accessible
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Phone call with Dr. Majid FarhadiFard at 09127521134
From where data/document is obtainable
Phone call with Dr. Majid FarhadiFard at 09127521134
What processes are involved for a request to access data/document
Phone call with Dr. Majid FarhadiFard at 09127521134