Therapeutic effects of oral zinc supplementation in acute watery diarrhea of children with moderate dehydration: a double blind randomized clinical trial
Objective: to assess the therapeutic effects of oral zinc supplementation in acute watery diarrhea of children with moderate dehydration. This double blind randomized clinical trial was done in Urmia. Methods: all 9 months to 5 years old children who were admitted with acute watery diarrhea and moderate dehydration at Children Ward of Motahari Hospital, Urmia, Iran in 2008 were recruited. After applying inclusion and exclusion criteria, patients were randomly allocated in two groups; receiving zinc sulfate (zinc syrup 1 mg/kg/day divided in two doses)+ oral rehydration solution (ORS) or placebo + ORS. A detailed questionnaire was filled daily for each patient by trained pediatrics residents containing required demographic characteristics, nutrition and hydration status and disease progression. Two groups compared for study outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201241580N2
Registration date:2012-02-17, 1390/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-17, 1390/11/28
Registrant information
Name
Shahsanam Gheibi
Name of organization / entity
Maternal and Childhood Obesity research Center, Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 6969
Email address
drgheibi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Challencor for research, Urmia University of Medical Sciences
Expected recruitment start date
2008-04-02, 1387/01/14
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of oral zinc supplementation in acute watery diarrhea of children with moderate dehydration: a double blind randomized clinical trial
Public title
Therapeutic effects of oral zinc supplementation in acute watery diarrhea of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all 9 months to 5 years old children who were admitted with acute watery diarrhea and moderate dehydration at Children Ward of Motahari Hospital, Urmia, Iran in 2008 were recruited. The exclusion criteria were diagnosed chronic disease (Cystic fibrosis, inflammatory bowel diseases, malabsorption); severe malnutrition (weight curve's was under percentage 3% for age); dysentery and bloody diarrhea confirmed with existence of red blood cell (RBC) or white blood cell (WBC) in stool examination (S/E); recent consumption of antibiotics; severe dehydration or persistent vomiting; recent consumption of zinc supplements (last month) and drug intolerance.
Age
From 1 year old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
320
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
Urmia University of Medical Sciences
Street address
Resalat Ave
City
Urmia
Postal code
Approval date
2008-12-02, 1387/09/12
Ethics committee reference number
39
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
Stool consistency
Timepoint
daily
Method of measurement
Mothers report
Secondary outcomes
1
Description
admission period
Timepoint
days of admission
Method of measurement
days recorded in dossier
Intervention groups
1
Description
Zinc Sulfate Syrup, 1mg/kg/day/BID
Category
Treatment - Drugs
2
Description
Placebo with similar taste, color and smell was applied with similar option (1 ml/kg/day) for control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Shahryar Kamali, pediatrics Resident
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chencellor for Research, Urmia Univesity of Medical Sciences
Full name of responsible person
Morteza Motazaker
Street address
Resalat Ave
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chencellor for Research, Urmia Univesity 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
Urmia University of medical Sciences
Full name of responsible person
Shahsanam Gheibi
Position
Pediatrics Gastroenterologist, Associate Professor
Other areas of specialty/work
Street address
Shahid Motahari Hospital
City
Urmia
Postal code
Phone
+98 44 1222 6969
Fax
Email
drgheibi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shahsanam Gheibi
Position
Pediatrics Gastroenterologist
Other areas of specialty/work
Street address
Shahid Motahari Hospital
City
Urmia
Postal code
5715744468
Phone
+98 44 1222 6969
Fax
Email
drgheibi@yahoo.com , drgheibi@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Shahsanam Gheibi
Position
Pediatrics Gastroentrologist, Associate Professor
Other areas of specialty/work
Street address
Shahid Motahari Hospital
City
Urmia
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)