|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR628 |
|
Date of registration:
|
15/03/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Controlled growth hormone study in children with Prader Willi Syndrome.
|
|
Scientific title:
|
Multicenter, randomized, controlled growth hormone study in children with Prader Willi Syndrome: effects on growth, body composition, activity level and psychosocial development. - N/A |
|
Date of first enrolment:
|
23/4/2002 |
|
Target sample size:
|
85 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=628 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Dederieke
Festen |
|
Address:
|
Dutch Growth Foundation,
Westzeedijk 106
3016 AH
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 2251533 |
|
Email:
|
d.festen@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
A.C.S.
Hokken-Koelega |
|
Address:
|
Erasmus Medical Center, Sophia Children's Hospital, Room number SP-3437,
P.O. Box 2060, Dr. Molewaterplein 60
3000 CB
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4636744 |
|
Email:
|
a.hokken@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Genetically confirmed diagnosis of Prader Willi Syndrome;
2. Age between 6 months and 16 years at start of the study;
3. Bone age less than 16 years.
Exclusion criteria: 1. Extremely low dietary intake;
2. Severe scoliosis (consult spinal surgeon);
3. BMI SDS > +3SDS;
4. In children > 3 years, height SDS < 0 unless weight for height> +2SDS.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Prader-Willi syndrome
|
|
Intervention(s)
|
Treatment with GH: Genotropin ® 1mg/m2/d s.c. vs. no GH-treatment.
Dietary and exercise advice.
|
|
Primary Outcome(s)
|
To asses effects of GH-treatment vs. no GH-treatment in children with PWS on:
height, weight, body composition,
muscle mass, muscle strength and daily life activity.
Cognition, behaviour and social emotional development. Resting Energy Expenditure.
Psychomotor development in infants.
|
|
Secondary Outcome(s)
|
|
To study the effect of additional dietary advise and physical exercise on body composition in children with PWS treated with GH vs, not treated with GH.
|
|
Secondary ID(s)
|
|
ISRCTN49726762
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
Pfizer
|
|