This study is a clinical trial on 150 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- Without dysentery that is confirmed by stool exam- Children with axillary temperature ≥ 38 ° are excluded from the study. Serum zinc level is measured by taking 5cc blood sampling on admission. Patients randomly assign into three groups. Experimental group1 receive Zinc sulfate1cc / kg of solution1% Razak Company and experimental group 2 receive Zinc gluoconate1cc / kg of solution1% Alhavy Company daily.The control group will receive like ORS solution 1cc / kg /daily. In three 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. The serum Zinc level in the end of diarrhea will be tested at discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123111145N3
Registration date:2013-03-10, 1391/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-10, 1391/12/20
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
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Zinc sulfate and Zinc gluconate on serum level of Zinc and improvement of acute diarrhea in children under 5 years
Public title
Comparing the effect of Zinc sulfate and Zinc gluconate on serum level of Zinc and improvement of acute diarrhea in children under 5 years
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.
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:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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
5th Kilometer, Ghotbe Ravandi Bulv, Kashan
City
Kashan
Postal code
Approval date
2013-02-17, 1391/11/29
Ethics committee reference number
4227/1/5/29/پ
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
Duration of diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
3
Description
Frequency of Diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
4
Description
Admission period
Timepoint
at discharge
Method of measurement
Days recorded in dossier
5
Description
Serum zinc level
Timepoint
on admission - at discharge
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Oral administration of Zinc sulfate 1cc / kg of solution 1% daily
Category
Treatment - Drugs
2
Description
Intervention group 2:
Oral administration of Zinc gluconate 1cc / kg of solution 1% daily
Category
Treatment - Drugs
3
Description
Control group: Oral administration of like ORS solution 1cc / kg /daily