Constitutional Growth Delay, Nutrition Disorders, Growth Disorders
Conditions
Keywords
GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature
Brief summary
The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.
Detailed description
Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.
Interventions
DRUGPediasure
With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.
DRUGGH
Growth Hormone will be 0.3mg/kg/week, given SC once daily.
Sponsors
Genentech, Inc.
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
7 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Boys 7-10 years old who are very short and below average in weight but otherwise healthy. * Delay in skeletal maturation \> 1 year.
Exclusion criteria
* Growth hormone deficiency * Chronic illness * Participation in high endurance athletics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height, weight, and body composition | 6month, 12month, 18month |
Secondary
| Measure | Time frame |
|---|---|
| Changes in total energy expenditure | 6month, 12month |
Countries
United States
Outcome results
None listed