Nutrients and Hormones: Effects in Boys With Disordered Growth
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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