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Sponsors and Collaborators: |
Nemours Children's Clinic Genentech |
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Information provided by: | Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT00139451 |
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.
Condition | Intervention | Phase |
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Constitutional Growth Delay Nutrition Disorders Growth Disorders |
Drug: Pediasure Drug: GH |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Nutrients and Hormones: Effects in Boys With Disordered Growth |
Estimated Enrollment: | 20 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 7 Years to 10 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 |
Principal Investigator: | Nelly Mauras, MD | Nemours Children's Clinic |
Study ID Numbers: | IRB # 04-016 |
Study First Received: | August 29, 2005 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00139451 |
Health Authority: | United States: Institutional Review Board |
GH Delayed Growth Energy Expenditure |
Puberty Nutrition Short Stature |
Growth Disorders Nutrition Disorders |
Pathologic Processes Disease |