Status:
COMPLETED
Growth Hormone Use in Adults With Prader-Willi Syndrome
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
16-60 years
Phase:
PHASE3
Brief Summary
The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss...
Detailed Description
The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss...
Eligibility Criteria
Inclusion
- 16 to 60 years old
- Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
- Low IGF-1 level (e.g.,≤25%) at baseline
- Ability to provide informed consent or availability of a suitable legally authorized representative
Exclusion
- Pregnancy
- Previous treatment with growth hormone
- Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
- History of severe scoliosis
- Heart disease
- Uncontrolled high blood pressure or history of stroke
- Morbid obesity (using PWS growth charts)
- Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00444964
Start Date
April 1 2005
End Date
January 1 2012
Last Update
January 8 2021
Active Locations (1)
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1
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108