Study of the effect of vitamin A supplement in the treatment of acute Gastroenteritis in children 1-5 year
Design
This study is a one-blinded clinical trial. The study population will be all patients referred to Mohammad Kermanshahi Hospital of Kermanshah.50 eligible patients will be selected conveniently and randomly assigned to two intervention and control groups.
Settings and conduct
This study that will be conducted in Mohammad Kermanshahi Hospital of Kermanshah is a one-blinded one that the data analyzer was kept blind to the allocation of study groups. Both groups will receive drug and placebo equivalents and the results will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 1 and 5 years; Children with acute diarrhea and vomiting
Exclusion criteria: Immunodeficiency patients and patients with allergy to bovine protein and lactose; Patients with chronic diarrhea and diarrhea caused by diseases (celiac-cystic fibrosis, etc.); Patients with drug-induced diarrhea; Patients with moderate to severe malnutrition
Intervention groups
The intervention group will receive 25,000 units of oral vitamin A twice daily for 4 days in addition to routine treatment. The control group will receive 25,000 units of distilled water twice daily for 4 weeks in addition to the routine treatment.
Main outcome variables
The number of vomiting episodes; The number of episodes of diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N140
Registration date:2020-02-23, 1398/12/04
Registration timing:prospective
Last update:2020-02-23, 1398/12/04
Update count:0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of vitamin A supplement in the treatment of acute Gastroenteritis in children 1-5 year
Public title
Study of the effect of vitamin A supplement in the treatment of acute Gastroenteritis in children 1-5 year
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 1 and 5 years
Children with acute diarrhea and vomiting
Exclusion criteria:
Immunodeficiency patients and patients with allergy to bovine protein and lactose
Patients with chronic diarrhea and diarrhea caused by diseases (celiac-cystic fibrosis, etc.)
Patients with drug-induced diarrhea
Patients with moderate to severe malnutrition
Age
From 1 year old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of25. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyzer was kept blind to the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.KUMS.REC.1398.1054
Health conditions studied
1
Description of health condition studied
Acute gastroenteritis
ICD-10 code
K52.9
ICD-10 code description
Noninfective gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
The number of vomiting episodes
Timepoint
Beginning and end of study
Method of measurement
Based on doctor observation and patient questions
2
Description
The number of episodes of diarrhea
Timepoint
Beginning and end of study
Method of measurement
Patient questions
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 25,000 units of oral vitamin A twice daily for 4 days in addition to routine treatment.
Category
Treatment - Drugs
2
Description
The control group will receive 25,000 units of distilled water twice daily for 4 weeks in addition to the routine treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Mohamadsaleh Kamrani
Street address
Helal Ahmar Crossroad, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
mitra_hemmati@Yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamadsaleh Kamrani
Position
Resident of Child
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroad, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
mitra_hemmati@Yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Hemmati
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroad, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
mitra_hemmati@Yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamadsaleh Kamrani
Position
Resident of Child
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Helal Ahmar Crossroad, Mohammad Kermanshahi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6713733135
Phone
+98 83 3721 8202
Email
mitra_hemmati@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
4 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail