Controlled growth hormone study in children with Prader Willi Syndrome.

Multicenter, randomized, controlled growth hormone study in children with Prader Willi Syndrome: effects on growth, body composition, activity level and psychosocial development.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26880

Enrollment

Registered

2006-03-15

Start date

2002-04-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader Willi Syndrome

Interventions

Treatment with GH: Genotropin ® 1mg/m2/d s.c. vs. no GH-treatment. Dietary and exercise advice.

Eligibility

Inclusion 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

Exclusion criteria: 1. Extremely low dietary intake; 2. Severe scoliosis (consult spinal surgeon); 3. BMI SDS > +3SDS; 4. In children > 3 years, height SDS +2SDS.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactDederieke Festen

Dutch Growth Foundation, Westzeedijk 106

d.festen@erasmusmc.nl+31 (0)10 2251533

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)