Status:
WITHDRAWN
Effects of Growth Hormone in Chronically Ill Children
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Hurler Syndrome
Cerebral Palsy
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief Summary
The specific aims for this study are - 1. To determine the effect of GH on height, height velocity, body weight and lean body mass. This specific aim tests the hypothesis that GH significantly improv...
Detailed Description
We will test our hypotheses by using a pilot study, in which we will recruit 18 chronically ill children from our clinical practice. We will obtain medical records for each patient 12 months prior to ...
Eligibility Criteria
Inclusion
- Ages 3-17 years
- Tanner stages 1-3
- Each child must have received adequate nutritional therapy supplied by aggressive oral supplementation, gastrostomy tube, or TPN for at least 1 year prior to enrollment.
- All children will have been referred for continued poor growth and will be less than the 10th percentile for height compared to age and gender normal values.
- low IGF-1 level at the time of enrollment (measured in the Endocrine clinic).
- Chronic illness to be included are Hurler Syndrome (MPS-1) with short stature and muscle wasting, cerebral palsy with muscle wasting, juvenile rheumatoid arthritis with muscle wasting and short stature, Crohn's disease and HIV infection.
Exclusion
- previous diagnosis with diabetes, chronic fevers (temp \> 101.5) or chronic bacterial infection.
- substantial change in steroid dosing, or having a formerly steroid negative patient start long-term-steroids (anticipated use greater that 7 days
Key Trial Info
Start Date :
February 3 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00286689
Start Date
February 3 2006
End Date
February 3 2006
Last Update
December 14 2018
Active Locations (1)
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1
Children's Medical Center of Dallas
Dallas, Texas, United States, 75390