Aim: to evaluate the effect of oral zinc sulfate syrup in children with acute gastroenteritis. Method: this study was performed as a randomized double blind trial. Overall 400 children admitted with acute gastroenteritis, who are 6-24 months breast fed infants with mild to moderate dehydration with at least 2 days of gastroenteritis whose parents fill the consent form. Patients was receiving complementary foods during last month and antibiotic during admission and patients with severe FTT were excluded from study. They were divided into two equal groups. The case group took oral zinc sulfate 22 mg daily and control group was given the placebo. Information was gathered with questionnaires and recorded precisely over 10 days. The outcome of this trial: assessment the improvement of symptoms and duration of disease in children under treatment with zinc sulfate in compression to placebo.
General information
Acronym
GE
IRCT registration information
IRCT registration number:IRCT138902203900N1
Registration date:2010-08-30, 1389/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-30, 1389/06/08
Registrant information
Name
Zohre Torabi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 4857
Email address
mohamad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2007-04-10, 1386/01/21
Expected recruitment end date
2009-08-10, 1388/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral zinc sulfate effect on the duration of treatment in children with acute gastroenteritis admitted in pediatrics ward
Public title
Assessment of oral zinc sulfate effect on the duration of treatment in children with acute gastroenteritis(GE) admitted in pediatrics ward
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 6-24 months breast fed infants with mild to moderate dehydration with at least 2 days of gastroenteritis whose parents fill the consent form. Exclusion criteria: receiving complementary foods during last month and antibiotic during admission, severe FTT.
Age
From 6 years old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences
City
Zanjan
Postal code
4515613191
Approval date
2010-05-30, 1389/03/09
Ethics committee reference number
19/3-3/1001
Health conditions studied
1
Description of health condition studied
Gastroenteritis
ICD-10 code
A09
ICD-10 code description
Diarrhoea and gastroenteritis of presumed infectious origin
Primary outcomes
1
Description
Improvement of symptoms
Timepoint
daily
Method of measurement
clinical assessment
Secondary outcomes
1
Description
weight gain
Timepoint
daily
Method of measurement
weight measurment with seca instrument
Intervention groups
1
Description
Control group: 5cc of dextrose water 5% as placebo, once daily
Category
Placebo
2
Description
Case group: 5cc of zinc sulfate (22 mg) once daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Zohre Torabi
Street address
Gavasang road
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University Of Medical Sciencs
Full name of responsible person
Alireza Biglari
Street address
Zanjan University of Medical Sciences
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University Of Medical Sciencs
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
Zanjan University of Medical Sciences
Full name of responsible person
Zohre Torabi
Position
Assistant prof, specialist of pediatic
Other areas of specialty/work
Street address
Gavasang road , Mousavi hospital
City
Zanjan
Postal code
4513956183
Phone
+98 24 1727 4857
Fax
+98 24 1413 1140
Email
drztorabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)