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The Effect Of Zinc Gloconate Supplementation in Children With Acute Diarrhea .

Protocol summary

Summary
According to recent studies on the effect of zinc on reducing diarrhea in developing and poor countries ,the aim of this study is to evaluate the effect of zinc in childrens with diarhhea based on their socioeconomic levels. About 70 children with diarrhea will participate in this study with ages between 6 months and 5 years. This survey is done in Emam Hossein Pediatric Hospital in Isfahan.The steps of this survey are as followed: 1. preparation of drug and placebo with same shape, size and color and blindly 2. fulfilling patients special forms including patient's age, duration of diarrhea and socioeconomic variables 3. consumption of drug 4. follow up in days 2, 5, 14 and 1 and 3 months after administration of drug 5. data entry and statistical analysis 6. unblinding cases and reporting outcomes Inclusion Criteria: 1. ages between 6 months and 5 years 2.duration of diarrhea between 24 and 72 hours 3.lack of any underlying disorder (For example Reflux,Asthma,Heart Disease,Epilepsy,Convulsion,FTT,Developmental Delay,Diabetes,Metabolic Disorder,Cancer) 4. No recent Major surgery around three months ago , Minor Surgery around one month ago. 5.No recent consumption of antibiotics in recent two weeks 6. No recent consumption of zinc supplementation in recent 6 months Exclusion Criteria: vomiting more than 2 times in 24h. If the patient has vomiting with zinc, they will treated. Decreasing diarrhea and decreasing respiratory infection are major incomes in this survey.

General information

Acronym
Zinc Gloconate
IRCT registration information
IRCT registration number: IRCT2015123125780N1
Registration date: 2016-11-17, 1395/08/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-17, 1395/08/27
Registrant information
Name
Naser Mostafavy
Name of organization / entity
Department of Pediatrics , School of Medical , Isfahan University of Medical Sciences, Hezar Jerib
Country
Iran (Islamic Republic of)
Phone
none
Email address
n_mostafavy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Zinc Gloconate Supplementation in Children With Acute Diarrhea .
Public title
The Effect Of Zinc Gloconate Supplementation In Treatment Of Diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1.Children with ages between 6 months and five years. 2. Children with diarrhea duration more than 24 hours and less than 72 hours 3. lack of any underlying disorder (For example Reflux,Asthma,Heart Disease,Epilepsy,Convulsion,FTT,Developmental Delay,Diabetes,Metabolic Disorder,Cancer) 4. No recent Major surgery in three months ago , Minor Surgery in one month ago. 5. No recent consumption of antibiotics in recent two weeks 6. No recent consumption of zinc supplementation in recent six months . Exclusion Criteria: vomiting more than two times in 24hours
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
Hezar Jarib Street , Isfahan
City
Isfahan
Postal code
8174643446
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
none

Health conditions studied

1

Description of health condition studied
acute dirrhea
ICD-10 code
K93
ICD-10 code description
Diseases of the digestive system

Primary outcomes

1

Description
durationof diarrhea. frequency of diarrhea,respiratory infection
Timepoint
2,14 days.3,6 months
Method of measurement
ask from parents ,filling the form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Zinc sulfate, 10 mg tablet taken orally, once daily, for 14 days, in children under 6 months Control group: placebo, 10 mg tablet taken orally, once daily, for 14 days, in children under 6 months
Category
Treatment - Drugs

2

Description
Intervention group: Zinc sulfate, 20 mg tablet taken orally, once daily, for 14 days, in children older than 6 months Control group: placebo, 20 mg tablet taken orally, once daily, for 14 days, in children older than 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr.Mosafavy-Dr.Soleymani
Street address
Imam Hossein Hospital.Imam Khomeini Street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Mostafavy
Street address
Hezar Jarib Street
City
Isfahan
Grant name
ندارم
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University 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
Esfahan University Of Medical Sciences
Full name of responsible person
Mrs.Vakili Zahra
Position
Responsible Of Scientific Unit
Other areas of specialty/work
Street address
Hezarjarib Street.Esfahan
City
Esfahan
Postal code
8174643446
Phone
+98 31 3792 8092
Fax
None
Email
None
Web page address
www.med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University Of Medical Sciences
Full name of responsible person
Dr.Mostafavy
Position
Professor Of Peditric Medicine Of Esfshan
Other areas of specialty/work
Street address
Emam Hossein Hospital
City
Esfahan
Postal code
none
Phone
+98 31 3387 6004
Fax
none
Email
n_mostafavy@med.mui.ac.ir
Web page address
none

Person responsible for updating data

Contact
Name of organization / entity
Emam Hossein Hospital
Full name of responsible person
Dr Mostafavy
Position
Professor Of Pediatric Esfahan
Other areas of specialty/work
Street address
HezarJarib Street.Esfahan
City
Esfahan
Postal code
none
Phone
+98 31 3387 6004
Fax
none
Email
n_mostafavy@med.mui.ac.ir
Web page address
none

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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