NCT01298180

Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).

Detailed description

Estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD) by the measure of the circulating rates of IGF-I under treatment.

Conditions

• Prader-Willi Syndrome
• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Growth hormone (Genotonorm® or Omnitrope®)	drug : the treatment will be begun in progressive dose by beginning by ¼ of the dose the first week, then ½ of the dose the second week, then 3/4 of the dose the third week and total dose the fourth week.
PROCEDURE	DEXA, blood tests, H.G.P.O, osseous age.	SPW, GHD, SPW-B : blood tests : centralized dosage H.G.P.O : adjusted to children's age.
PROCEDURE	biopsy	Biopsy : Cutaneous and fat tissue biopsy.

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-02-17
• Last updated: 2021-09-24

Locations

26 sites across 1 country: France