- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131349
Zinc and Iron in Children With Short Stature (zincandiron)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard.
Approximately 3% children in any population will be short, amongst which half will be physiological (familial or constitutional) and half will be pathological.
It is estimated that approximately 60%-80% of all short children at or below 2standerd deviation fit the definition of idiopathic short stature.
The growth and development of human require an adequate supply of many different nutritional factors. Nutritional deficiencies causing short stature include: those associated with stunting as: protein and zinc, nutrient associated with rickts as :vitamin D, and those with bone abnormalities as: cupper,zin,and vitamin c Insufficient nutrition tends to lead to short stature with a delayed pattern of growth. Under-nutrition can be isolated (eg, caused by inadequate food supply or self-imposed restriction, such as fear of obesity), or it may be a component of an underlying systemic disease that interferes with food intake or absorption, or increases energy needs. The hallmark of under-nutrition is low weight-for-height .
Trace elements are dietary mineral that are present in very minute quantities (less than 0.01%),they divided into three groups (WHO classification): Essential elements such as iodine and zinc ,Probably essential elements such as manganese and silicon , Potentially toxic elements such as fluoride,lead,cadmium, mercury, & Lithium.
Trace elements play significant functions as growth,oregulation of gene expression, immunity,the endocrine system, brain development, and the cell protection system. An adequate micronutrient intake is crucial for health, particularly in infants, children and adolescents ,deficiency in micronutrients can affect growth and development, particularly during periods of rapid growth.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asiut, Egypt
- Engy dawood
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• children of both sexes.
- Age range: 4-18 years.
- patients fulfilling criteria of short stature.
- height is 2 standard deviations below normal .
- initial height below the third percentile on Egyptian growth chart. • Number of patients: will include 50 cases
Exclusion Criteria:
- Skeletal dysplasia.
- Chromosomal anomalies
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
column heading in tables
history examinations investigation:serum zinc and iron
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history ,examination,investigations
|
row heading in tables
history examinations investigation:serum zinc and iron
|
history ,examination,investigations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
zinc and iron in children with idiopathic short stature
Time Frame: 6 months
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Assessment of the serum level of zinc and iron in idiopathic with short stature.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- assiut university17100104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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