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Zinc and Iron in Children With Short Stature (zincandiron)

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ClinicalTrials.gov Identifier: NCT03131349
Recruitment Status : Unknown
Verified April 2017 by engy dawood, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
engy dawood, Assiut University

Brief Summary:
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 zinc and iron have important role in growth for children

Condition or disease Intervention/treatment
Zinc; Deficiency With Anemia Diagnostic Test: serum zinc and iron

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Zinc and Iron in Children With Short Stature
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Iron

Group/Cohort Intervention/treatment
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history examinations investigation:serum zinc and iron
Diagnostic Test: serum zinc and iron
history ,examination,investigations

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history examinations investigation:serum zinc and iron
Diagnostic Test: serum zinc and iron
history ,examination,investigations




Primary Outcome Measures :
  1. zinc and iron in children with idiopathic short stature [ Time Frame: 6 months ]
    Assessment of the serum level of zinc and iron in idiopathic with short stature.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
50 cases will be included :35 child with idiopathic short stature and 25 as controls aging from4-18 years old coming to endocrinology clinic at Assuit University Children Hospital will be investigated for serum of zinc and iron
Criteria

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

Additional Information:

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Responsible Party: engy dawood, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03131349     History of Changes
Other Study ID Numbers: assiut university17100104
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: patients aging 2-18years old will be dbtained at the start of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Iron
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs