This study is a clinical trial on 200 children aged 1-5 years.Patients admitted with complaints of acute watery diarrhea in Beheshti Hospital with the following characteristics are enrolled: Aged 1-5 years- With out dysentery that is confirmed by stool exam- Children with axillary temperature ≥ 38 ° are excluded from the study. Patients randomly assign into two groups (experiment or control). Experimental group receive one dose Intramuscular vitamin A 1000 IU/kg. The control group will not receive vitamin A. In both groups, treatment protocols for watery acute diarrhea shall be conducted. Frequency and duration of diarrhea within the past 24 hours is recorded by asking mothers
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102411145N2
Registration date:2012-11-10, 1391/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-10, 1391/08/20
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-11-03, 1392/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of vitamin A on watery diarrhea in children between 1-5 years old
Public title
The evaluation of the effect of vitamin A on watery diarrhea in children between 1-5 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children hospitalized with acute gastroenteritis in Shahid Beheshti hospital; Aged 1 - 5 years.
exclusion criteria: Dysentery confirmed by stool exam; Axillary temperature equal to or more than 38 ° C; Underlying disease that can not be given injections of vitamin A.
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
پ/29/5//1/2892
Health conditions studied
1
Description of health condition studied
Acute Watery Diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Stop Diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
2
Description
Frequency of Diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
3
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
Secondary outcomes
1
Description
Admission period
Timepoint
Days of admission
Method of measurement
Days recorded in dossier
Intervention groups
1
Description
Intervention: intramuscular injection of Vitamin A 1000 IU/kg
Category
Treatment - Drugs
2
Description
Control group: without Vitamin A
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr. Mehrdad Hossein pour
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Sharif
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv. Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
mrsharifmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Sharif
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)