Status:
COMPLETED
Role of Nutrition and Hormones in Boys With Disordered Growth
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Short Stature
Constitutional Delay of Growth and Development
Eligibility:
MALE
7-10 years
Phase:
PHASE2
Brief Summary
This study will determine whether adding more calories to the diet helps boys with growth problems grow better while being treated with Nutropin, a growth hormone that is used to help children grow ta...
Detailed Description
We propose a pilot study to examine the role of nutrition and its interaction with growth hormone (GH) therapy in boys with very short stature who also have delayed bone age characteristic of constitu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Age 7-10 years, genital Tanner 1, significant short stature (current height less than 2.25SD below the mean for age), body mass index (BMI) less than 25th percentile for age, weight-for-height less than 25th percentile, bone age less than 10 years and with delay greater than 1 year below chronological age, minimum of 6 months of documented height measurements performed in the pediatric endocrinology clinic using a stadiometer to permit accurate calculation of baseline growth velocity at time of enrollment, otherwise normal physical exam, expressed desire for medical intervention to promote growth, and assessment by a pediatric endocrinologist that the boy qualifies for GH treatment according to current FDA guidelines for the use of GH in children with idiopathic short stature (i.e., children who are determined not to have growth hormone deficiency but have height less than -2.25SD below the mean for age).
- EXCLUSION CRITERIA
- History of major/chronic illness, anosmia/hyposmia, any clinically significant abnormalities on biochemical testing. GH deficiency would be excluded prior to enrollment based on anthropometric and GH stimulation test data. Endocrinopathies (except stable thyroid replacement), skeletal dysplasias, participation in highly competitive endurance sports activities, diagnosis of ADHD with use of stimulant medication in the previous 3 months will also be exclusion criteria.
Exclusion
Key Trial Info
Start Date :
January 19 2005
Trial Type :
INTERVENTIONAL
End Date :
October 2 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00102258
Start Date
January 19 2005
End Date
October 2 2007
Last Update
July 2 2017
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207