Clinical Trial: Nutrients and Hormones: Effects in Boys With Disordered Growth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Nemours Children's Clinic

Current Primary Outcome: Change in height, weight, and body composition [ Time Frame: 6month, 12month, 18month ]

Original Primary Outcome: change in height,weight,body composition, energy usage.

Current Secondary Outcome: Changes in total energy expenditure [ Time Frame: 6month, 12month ]

Original Secondary Outcome:

Information By: Nemours Children's Clinic

Dates:
Date Received: August 29, 2005
Date Started: May 2004
Date Completion:
Last Updated: October 11, 2011
Last Verified: October 2011