As an essential micronutrient, zinc has a critical role in human growth in different stages of life Efficacy of zinc supplementation on improvement of growth of infants and prepubertal children has been evaluated in several studies in Iran and other countries. Little is known, however, about efficacy of zinc on post-pubertal growth of children. In a randomized clinical trial , 9-18 year old healthy referred children to Pediatric Growth Clinic of Shahid Sadoughi Hospital, Yazd , Iran will be enrolled and randomly assigned to two groups to receive daily supplementation of single dose of 5 mg zinc sulfate for 4 months or placebo. The children will be followed up for 4 months and weight gain velocity , height gain velocity , before and four months after intervention serum zinc level and clinical side effects will be evaluated in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305302639N13
Registration date:2013-06-07, 1392/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-07, 1392/03/17
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private, Shahid Sadoughi University of Medical Sciences,Yazd,Iran
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-11-06, 1390/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of zinc supplementation on improvement of weight and height growth of healthy 9-18 year children
Public title
Efficacy of zinc supplementation on weight and height growth of healthy 9-18 year children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1- children aged 9-18years
2- being healthy
3- having normal serum zinc level ( plasma level of 70-158 μg/dL)
Exclusion criteria:
1- receiving a zinc combination within the past three months
2- presence of any chronic systemic diseases(endocrine ,cardiac, renal, metabolic, malignancy, rheumatologic , etc )
3- presence of acrodermatitis enteropathica
4- presence of mental retardation
5- being underweight based on NHANES III ( National Health and Nutrition Examination Survey III) curves
6- being short stature based on NHANES III ( National Health and Nutrition Examination Survey III) curves
7- having severe malnutrition.
Age
From 9 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Bahonar Square,Central building of University
City
Yazd
Postal code
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
174321
Health conditions studied
1
Description of health condition studied
malnutrition
ICD-10 code
K92.9
ICD-10 code description
Disease of digestive system, unspecified
Primary outcomes
1
Description
Weight
Timepoint
two Before, two and four months after starting of the intervention
Method of measurement
children digital weighing scale
2
Description
height
Timepoint
Before , two and four months after starting of the intervention
Method of measurement
stadiometer
3
Description
Serum zinc level
Timepoint
Before and four months after starting of the intervention
Method of measurement
laboratory by atomic absorption spectrometry
Secondary outcomes
1
Description
side effects
Timepoint
During intervention
Method of measurement
Clinical exam and asking from person
Intervention groups
1
Description
daily supplementation of single dose of 5 mg zinc sulfate for four consecutive months
Category
Treatment - Other
2
Description
placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Growth Clinic of Shahid Sadoughi Hospital, Yazd , Iran