This study is a clinical trial on 100 children aged 1-5 years admitted in Shahid Beheshti Hospital with complaints of fever and bloody diarrhea in 2014. Dysentery is confirmed by stool exam. Patients randomly assign into two groups. Experimental group receive 20 mg (20 ml) zinc sulfate solution and the control group will receive 20 ml placebo solution for 5 days. Treatment protocols for dysentery shall be conducted in two groups. Duration of fever and bloody diarrhea and stool frequency within the past 24 hours will be recorded by the question of mother and study of dossier.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051611145N8
Registration date:2014-06-09, 1393/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-09, 1393/03/19
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
2014-05-26, 1393/03/05
Expected recruitment end date
2014-11-26, 1393/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on the severity and duration of bloody diarrhea in children
Public title
Effect of zinc supplementation on the severity and duration of bloody diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children hospitalized with fever and bloody diarrhea; Aged 1-5 years
Exclusion criteria: Malnutrition; Systemic diseases
Age
From 1 year old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-05-07, 1393/02/17
Ethics committee reference number
29/5/1/621/پ
Health conditions studied
1
Description of health condition studied
Bloody diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Study of records and question of the mother
2
Description
Stop fever
Timepoint
Every 6 hours
Method of measurement
Study of records and question of the mother
3
Description
Stop bloody diarrhea
Timepoint
Daily
Method of measurement
Study of records and question of the mother
4
Description
Frequency of diarrhea
Timepoint
Daily
Method of measurement
Study of records and question of the mother
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
At discharge
Method of measurement
Study of records
Intervention groups
1
Description
Intervention group: Daily oral administration of 20 mg (20 ml) zinc sulfate for 5 days
Category
Treatment - Drugs
2
Description
Control group: Daily oral administration of 20 ml placebo for 5 days