Recent studies reported that zinc significantly reduces duration and severity of acute diarrhea in children. Zinc deficiency is prevalent in children in developing countries. Supplemental zinc provides therapeutic benefits in diarrhea. Our aim was to evaluate the effect of zinc supplementation on diarrhea duration and severity among children aged <5 y.
This study was a double–blind, randomized, placebo controlled trial. Children (228 subjects) who hospitalized with an acute diarrhea were randomly assigned in two groups A and B to receive 20 mg Zn sulfate or placebo(glucose 5%), Children who hospitalized with acute diarrhea inclused in study and whom had perior of hospitalizition and severe illness in two last months exclused.Then duration and severity of diarrhea were assessed during the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103065989N1
Registration date:2011-05-30, 1390/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-30, 1390/03/09
Registrant information
Name
Afrouz Mardi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3327 1159
Email address
a.mardi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Official- Research Assistant of Ardabil University of Medical Sciences
Expected recruitment start date
2005-03-21, 1384/01/01
Expected recruitment end date
2006-03-20, 1384/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Zinc Supplementation on Diarrhea Duration and Severity in Hospitalized Children in Ardabil
Public title
Zinc Supplementation and Diarrhea in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Children who hospitalized with acute diarrhea
Ixclusion: Children who had perior of hospitalizition and severe illness in two last months.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
There aren't the other design featurs
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah street- Ardabil
City
Ardabil
Postal code
Approval date
2005-10-06, 1384/07/14
Ethics committee reference number
82165
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
A09
ICD-10 code description
Diarrhoea and gastroenteritis of presumed infectious origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Number of hospitalization days were used as duratin time.
Method of measurement
Number of hospitalized days
2
Description
Severity of diarrhea
Timepoint
Daily during the hospitalization time
Method of measurement
Number of defecation in day
Secondary outcomes
1
Description
There weren't secondary outcome measure
Timepoint
There weren't secondary outcome measure
Method of measurement
There weren't secondary outcome measure
Intervention groups
1
Description
Intervention group received 20 mg zinc sulfate in dextrose 5% daily plus their routine drugs during the hospitalization time.
Category
Treatment - Drugs
2
Description
Control group received 5 cc dextrose 5% daily plus their routine drugs during the hospitalization time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Mrs Panahi Farahnaz
Street address
Varzesh Square -Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil Uinversity of Medical Sciences
Full name of responsible person
Dr Peeri Hadi
Street address
Daneshgah Street- Medical School- Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil Uinversity 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
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afrouz Mardi
Position
Master Science/ Lecturer
Other areas of specialty/work
Street address
Health School
City
Ardabil
Postal code
5618953141
Phone
+98 45 1552 0477
Fax
+98 45 1551 3775
Email
a.mardi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afrouz Mardi
Position
master science / lecturer
Other areas of specialty/work
Street address
Health School
City
Ardabil
Postal code
5618953141
Phone
+98 45 1552 0477
Fax
+98 45 1551 3775
Email
a.mardi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afrouz Mardi
Position
Master Science/ Lecturer
Other areas of specialty/work
Street address
Health School- Ardabil University of Medical Sciences- Ardabil
City
Ardabil
Postal code
56189 53141
Phone
+98 45 1552 0477
Fax
+98 45 1551 3775
Email
a.mardi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)