Comparison of the administration of vitamin D3 and N acetylcysteine tablets in COVID-19 patients and their effect on recovery
Design
A randomised factorial trial with single blinded outcome assessment
Settings and conduct
A randomised factorial trial with single blinded study was performed at Ayatollah Taleghani Hospital in Abadan This study was conducted on 100 patients with COVID-19 admitted to the infectious ward of Ayatollah Taleghani Hospital. Written consent was obtained for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive COVID-19 with severe symptoms Exclusion criteria: Take a drug other than the medication mentioned
Intervention groups
The first group only receiving Standard protocol national drugs
The second group receiving Standard protocol national drugs plus vitamin D3 50,000 units once a week.
The third group receiving Standard protocol national drugs plus 600mg daily N acetylcysteine.
The fourth group receiving Standard protocol national drugs drugs with a 500,000 unit dose of vitamin D3 once a week with 600mg N acetylcysteine daily.
Main outcome variables
changes in level of consciousness, breathing rate, arterial oxygen saturation and changes in laboratory factors, gastrointestinal disorder, number of days of hospitalization and mortality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046850N1
Registration date:2020-03-29, 1399/01/10
Registration timing:registered_while_recruiting
Last update:2020-03-29, 1399/01/10
Update count:1
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Sara Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
s.mobarak@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin D3 and N-acetylcysteine prescription in COVID19 patients and their effect on recovery process
Public title
Comparison of vitamin D3 and N-acetylcysteine prescription in COVID-19 patients and their effect on recovery process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a chest CT scan to confirm Covid 19 Having Clinical symptoms of covid 19 including fever, muscle pain, shortness of breath, dry cough, sore throat, runny nose Confirmation of covid19 by an infectious disease physician Having consent to participate in the intervention
Exclusion criteria:
Pregnant and lactating womenThose taking losartan and captopril.Those with a history of intestinal ulcers or gastrointestinal bleeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
1
Appropriate specimens are generally collected from the respiratory tract
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is 6 unit block randomization. Unit of randomization is individual. Tools for randomization is a computer software. Sealed envelopes were used for allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in this study are blind and the drug used in both groups is similar in appearance. So patients do not understand which group they are in.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154 061
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.ABADANUMS.REC.1398.118
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Other coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Shortness of breath
Timepoint
Time to get the Corona test positive _14 days after test positive
Method of measurement
Using oral thermometer and Improve symptoms
2
Description
Cough
Timepoint
Time to get the Corona test positive _14 days after test
Method of measurement
Clinical observation and examination
3
Description
Chills
Timepoint
Time to get the Corona test positive _14 days after test positive
Method of measurement
Clinical observation and examination
4
Description
Night sweats
Timepoint
Time to get the Corona test positive _14 days after test positive
Method of measurement
Clinical observation and examination
Secondary outcomes
empty
Intervention groups
1
Description
Group I: Receivers of standard national protocol drugs
Category
Treatment - Drugs
2
Description
Intervention group: Group II: Drug recipients of National Medicines Standard Protocol + (Perl Vitamin D3 50,000 units) once a week
Category
Treatment - Drugs
3
Description
Intervention group: Group III: National standard drug + N acetylcysteine (NAC) tablets receiving 600mg every 12 hours for 14 days
Category
Treatment - Drugs
4
Description
Intervention group: Group IV: National standard protocol drug + (Perl vitamin D3 50,000 units) once a week + N acetylcysteine (NAC) tablet 600mg every 12 hours for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Sara Mobarak
Street address
Ayatollah Taleghani Hospital. University Blvd. Nurse Square. Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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