The purpose of this study is to investigate the effect of zinc sulfate supplementation on prevention of diarrhea due to coamoxiclave.This study is randomized clinical trial. A Total of 120 children suffering from otitis media that have indication of using coamoxiclave were enrolled. Exclution criteria is severe malnutrition; using antibiotic in 2 recent week; chronic illness; systemic disease that need to hospitalized; severe dehydration; fluide intoleranc; using immunosuppressive drug; using drugs causing diarrhea or constipation; using zinc supplement in two recent month; Parent who do not cooperate. After interview and accept parent satisfaction،their children were enrolled in this study. We will prescribe zinc sulfate 2mg/kg/day and also coamoxiclave 80mg/kg/day for intervention group but controll group only recieve coamoxiclave at the same dosage. Using drugs continue for seven days in this study. The researcher investigate patient condition about the number of defication on third and seventh days. Then we will collect data in questionnaire . Primary outcome is to consider number of defication and the secondry outcomes are weight loss and hospitalization
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100119354N1
Registration date:2014-11-15, 1393/08/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-15, 1393/08/24
Registrant information
Name
Maryam AlSadat Yazdanparast
Name of organization / entity
Shahid Sadoughi University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 5793
Email address
yazdanparastmaryam89@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Shahid Sadoghi University of Medical Science
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc sulfate on prevention of diarrhea due to coamoxiclave in pediatric 6-60 MO
Public title
The effect of zinc sulfate on prevention of diarrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 6 to 60 mo with otitis media
Exclution criteria: Severe Malnutrition; Using antibiotic in 2 recent week; Chronic illness; systemic disease that need to hospitalized; Severe dehydration; fluide intolerance; Using immunosuppressive drugs; Using drugs causing diarrhea or constipation; Using zinc supplement in two recent month; Parent who do not cooperate
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoghi University of Medical Science
Street address
Bahonar sq, Yazd
City
Yazd
Postal code
Approval date
2014-03-18, 1392/12/27
Ethics committee reference number
257428 /1/17/ پ
Health conditions studied
1
Description of health condition studied
Non infective enteritis and colitis
ICD-10 code
k52
ICD-10 code description
Other noninfective gastroenteritis and colitis
Primary outcomes
1
Description
Number of defecation in day
Timepoint
Third and seventh day of treatment
Method of measurement
Asking from mothers of patients
Secondary outcomes
1
Description
Hospitalization
Timepoint
First day until seventh day of treatment
Method of measurement
Asking from mothers of patient
2
Description
Weight loss
Timepoint
Seventh day of treatment
Method of measurement
Weighting patient by resident
Intervention groups
1
Description
Intervention group: Zinc sulfate syrup (manufacture by Alhavi Co, Iran) 2mg/kg/day divided in two equal dosage and coamoxiclave syrup (manufacture by Abidi Co, Iran) 80mg/kg/day divided in tree equal dosage will prescribe whitin seven days
Category
Prevention
2
Description
Control group: Coamoxiclav (manufacture by Abidi Co, Iran) 80mg/kg divided in tree equal dosage will prescribe whitin seven days