Nutrients and Hormones: Effects in Boys With Disordered Growth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutrients and Hormones: Effects in Boys With Disordered Growth

Conditions
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Constitutional Growth Delay, Nutrition Disorders, Growth Disorders

Intervention / Treatment
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* Drug: Pediasure
* Drug: GH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition and Growth Hormone<br> | Drug: Pediasure<br>* 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.<br>Drug: GH<br>* Growth Hormone will be 0.3mg/kg/week, given SC once daily.<br>|
| Active Comparator: Observation and Growth Hormone<br> | Drug: GH<br>* Growth Hormone will be 0.3mg/kg/week, given SC once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in height, weight, and body composition |  | 6month, 12month, 18month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total energy expenditure |  | 6month, 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature