Zinc sulfate is required for growth and development of human babies and its deficiency cause growth failure in children. In this study we will elect 7-12 years old children in five schools of Mashhad city as cluster randomized clinical trial in two groups, case and control, after coordination with educational organ. In case group they will receive 20 mg zinc sulfate as syrup and in control group 20 mg dextrose water as placebo. They will follow up during 6 months. Weight, length, arm circumference will measure for growth pattern and Time On Target for motor function in before, 3 months and 6 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711021162N9
Registration date:2009-02-16, 1387/11/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-02-16, 1387/11/28
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2009-02-19, 1387/12/01
Expected recruitment end date
2009-07-22, 1388/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on Physical growth and psychomotor function of school children
Public title
Effect of zinc supplementation on Physical growth and psychomotor function of school children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:
School children, 7-12 years old, healthy children, agree mentioned parents.
Exclusion criteria:
Prematurity or low birth weight, chronic disease (marasmus, cystic fibrosis,…), reject of drug by child
Age
From 7 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Vice chancellor for research of Mashhad university of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2008-12-29, 1387/10/09
Ethics committee reference number
87/108377
Health conditions studied
1
Description of health condition studied
Effect of zinc supplementation on Physical growth
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development
2
Description of health condition studied
Effect of zinc supplementation on psychomotor function
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
psychomotor function
Timepoint
befor, 3 months after, 6 months after
Method of measurement
Time On Target
2
Description
Physical growth
Timepoint
befor, 3 months after, 6 months after
Method of measurement
Balance ,centimeter
Secondary outcomes
empty
Intervention groups
1
Description
control: 20 mg placebo
Category
Placebo
2
Description
case:20 mg zinc supplementation daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
five schools in Mashhad city
Full name of responsible person
Dr.Ashraf mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr jalil tavakol afshari
Street address
Ghoreshi bulding-daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)