Protocol summary

Summary
1.Objectives:In developing countries,reduced calorie intake can cause delay in growth and development of children. Growth delay is an important reason that can cause cognitive problems in children.this problem not only play an important role in children's talent but can improve immunity of these children.It seems that in our society, unnecessary zinc supplement is used in a wide spectrum.The goals are to determine prevalence of kinds of food behavior in children and organic reasons (anemia,...)and the relation between kind of behaviors and anorexia patterns and frequency of zinc supplement usage and level of Zn, mg and iron and mean of micro and macro nutrients and mean of calories and anorexia pattern before and after drug and placebo usage. 2.Design:This survey is designed first to analyze the etiologic factors of anorexia in preschool children and also analysis of zinc effect in this regard. 3.Setting and conduct:This survey is in two parts: first, children aged between 2 to 6 years will be studied and their mothers will be interviewed to fill in a questionnaire; then in part two, in a triple masked study, 48 cases and 48 controls will be selected. 4.Participants including major eligibility criteria:Inclusion criteria : age 2 to 6 y ;chief complaint of anorexia; not having any disability;not using any supplementation. Exclusion criteria: low compliance of family, dislike of children to use drug or placebo; gastrointestinal complications in the group receiving zinc . 5.interventions: The case group will receive 10 mg of zinc syrup for 3 months and control groups that uses placebo for 3 months. 6. The main outcome measures are: changes in children food behavior, frequency of iron,zinc,or magnesium deficiencies,intake of calories, protein,carbohydrate and fat

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302061434N7
Registration date: 2013-05-01, 1392/02/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-01, 1392/02/11
Registrant information
Name
Roya Kelishadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
kelishadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences, Thesis.
Expected recruitment start date
2013-02-08, 1391/11/20
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of etiologic factors of anorexia, and the frequency of using zin supplements in preschool children referred to Pediatric clinics affiliated to Isfahan University of Medical Sciences in 2013, and determination of the effects of zinc on improving their appetite
Public title
Assessment of etiologic factors of anorexia, and the frequency of using zin supplements in preschool children referred to Pediatric clinics affiliated to Isfahan University of Medical Sciences in 2013, and determination of the effects of zinc on improving their appetite
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion/exclusion criteria : age 2 to 6 y old;c.c of loss of appetite;loss of disabillity;not using any supplementation ;not distribution ;dislike to use drug or plassebo; GI complication
Age
From 2 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of faculty of Medicine, Isfahan University of Medical Sciences
Street address
Hezarjerb Ave
City
Isfaahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
111111

Health conditions studied

1

Description of health condition studied
Anorexia in preschool children
ICD-10 code
R63.0
ICD-10 code description
Loss of appetite

Primary outcomes

1

Description
children food behavior
Timepoint
at the beginnig and 3 months after
Method of measurement
questionaire CEBQ

2

Description
organic reasons
Timepoint
at the beginnig
Method of measurement
Labratory

3

Description
zn mg iron
Timepoint
at the beginnig and 3 months after
Method of measurement
labratory

Secondary outcomes

1

Description
height
Timepoint
at the beginnig and 3 months after
Method of measurement
cm

2

Description
anorexia criteria
Timepoint
at the beginnig and 3 months later
Method of measurement
questionnaire

3

Description
calorie intake
Timepoint
at the beginnig and 3 months after
Method of measurement
questionaire

Intervention groups

1

Description
The case group receive zinc sulfate syrup for 3 months, name of substance:zinc sulfate, chemical constant: zinc sulfate. chemical constant:syrup/usage:daily/dosage:5 cc/ time of usage:3 months
Category
Treatment - Drugs

2

Description
The control group receive placebo similar to zinc sulfate syrup for 3 months .name of substance: placebo/chemical constant:syrup/usage:daily/dosage:5 cc/ time of usage:3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan university clinics
Full name of responsible person
Pediatric clinics affiliated to Isfahan University of Medical Sciences
Street address
Pediatric clinics, Imam Hossein Hospital, Imam Khomeini St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Isfahan university of medical science،Hezarjerib Ave ،Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Roya Kelishadi/Dr Majid Khademian/Dr Neda Farhangpajhooh
Position
MD,Professor/MD,Assistant Professor /MD,Resident
Other areas of specialty/work
Street address
Imam Hossein Hospital, Imam Khomeini St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
kelishadi@med.mui.ac.ir ; fpneda@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Roya Kelishadi/Dr Majid Khademian/Dr Neda Farhangpajhooh
Position
MD/MD/MD
Other areas of specialty/work
Street address
Imam Hossein Hospital, Imam Khomeini St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
kelishadi@med.mui.ac.ir; fpneda@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical science
Full name of responsible person
Dr Roya Kelishadi/Dr Majid Khademian/Dr Neda Farhangpajhooh
Position
MD/MD/MD
Other areas of specialty/work
Street address
Imam Hossein Hospital, Imam Khomeini St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
kelishadi@med.mui.ac.ir;fpneda@yahoo.com
Web page address

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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