Investigating the effect of single dose of vitamin C on improving pneumonia in children 2 to 12 years of age
Design
Clinical trial with control group,two arm parallel group randomised trial with blinded , randomized, phase 3 on 100 patients. Www.randomization.com was used to randomize
Settings and conduct
The study was performed on children aged 2 to 12 with hospitalized pneumonia at Dr. Sheikh Hospital, which is divided into two groups: case and control. The control group received a single dose of placebo and the case group received a single dose of 500 mg of vitamin C. Participants and evaluators do not know are being in which group.
Participants/Inclusion and exclusion criteria
Children 2 to 12 years of age with pneumonia with no history of cystic fibrosis, bronchiectasis, acute and chronic renal failure, malnutrition, vitamin C intake in the past month, congenital heart disease, and mechanical ventilation
Intervention groups
Prescribing vitamin C as a single dose of 500 mg to children aged 2 to 12 years with pneumonia
Main outcome variables
AFever, tachypnea, cyanosis, respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101106005114N3
Registration date:2020-06-18, 1399/03/29
Registration timing:prospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Farhad Heydarian
Name of organization / entity
Mashhad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2469
Email address
heydarianf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin C administration on improving pneumonia in children 2 to 12 years of age
Public title
The effect of vitamin C in the treatment of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 12 years of age who have been given a definitive diagnosis of pneumonia according to clinical signs and graphics
Exclusion criteria:
Existence of underlying disease such as cystic fibrosis, bronchiectasis, acute or chronic kidney disease
Vitamin C intake over the past 1 month
The patient is intubated
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method has been used. This method is done through a table of random numbers using the site www.randomization.com. Accidental hiding was done using closed envelopes in such a way that the envelopes were prepared and printed by one of the members of the research team and random numbers with the help of the above site and inside the envelope. The envelopes were closed and the contents could not be seen from the outside. First, the purpose of the study was explained to the person who meets the conditions, and if desired, the person signed a conscious consent form, took an envelope and opened it, and entered the intervention or control group based on the contents of the person's envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Failure to inform the participant and evaluate the result
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 23, Daneshgah Ave., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
917351358
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.mums.medical.rec.1397.011
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J15.9
ICD-10 code description
Unspecified bacterial pneumonia
Primary outcomes
1
Description
Evaluation of fever every 6 hours by the evaluator and registration in the file
Timepoint
6، 12، 18، 24، 30، 36، 42، 48، 54، 60 hours
Method of measurement
Assessment of fever through an axillary thermometer
2
Description
Evaluate the number of breaths every 6 hours by the evaluator and record in the file
Timepoint
6، 12، 18، 24، 30، 36، 42، 48، 54، 60 hours
Method of measurement
Evaluation of the number of breaths through clinical examination and counting the number of breaths per minute by the evaluator and registration in the file
3
Description
Evaluation of Oxygen saturation level every 6 hours by the evaluator and record in the file
Timepoint
6، 12، 18، 24، 30، 36، 42، 48، 54، 60 hours
Method of measurement
Evaluation of oxygen saturation level through oximeter pulse by the evaluator and registration in the file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving a single dose of vitamin C 500 mg.
Category
Treatment - Drugs
2
Description
Control group:receiving placebo as a single dose and in terms of drug form is quite similar to vitamin C 500 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Farhad Heydarian
Street address
No 3 , Dr. Sheikh Street
City
Mashhad
Province
Razavi Khorasan
Postal code
917351358
Phone
+98 51 3726 9021
Email
HeydarianF@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
No. 23, Daneshgah Ave.,Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
917351385
Phone
+98 51 3841 2180
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
80
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
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Heydarian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 3, Dr. sheikh street
City
Mashhad
Province
Razavi Khorasan
Postal code
917351358
Phone
+98 51 3726 9021
Email
HeydarianF@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Heydarian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 3, Dr sheikh street
City
Mashhad
Province
Razavi Khorasan
Postal code
917351385
Phone
+98 51 3726 9021
Email
HeydarianF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Heydarian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 3, Dr sheikh street
City
Mashhad
Province
Razavi Khorasan
Postal code
917351385
Phone
+98 51 3726 9021
Email
HeydarianF@mums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
The results of the study, such as the effect of vitamin C on the improvement of clinical symptoms of pneumonia, such as fever and tachypnea and cyanosis, in both case and control groups
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions, medical students
Under which criteria data/document could be used
At the request of researchers working in academic and scientific institutions, medical students
From where data/document is obtainable
To the author in charge of the article, Dr. Farhad Heydarian
What processes are involved for a request to access data/document