Nutrients and Hormones: Effects in Boys With Disordered Growth

Phase 2

Completed

• Conditions: Constitutional Growth Delay; Growth Disorders; Nutrition Disorders
• Interventions: Drug: Pediasure; Drug: GH

• Registration Number: NCT00139451
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Primary Completion: 2007-12
• Study Completion: 2010-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Read More

Exclusion Criteria

• Growth hormone deficiency
• Chronic illness
• Participation in high endurance athletics

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition and Growth Hormone	GH	-
Nutrition and Growth Hormone	Pediasure	-
Observation and Growth Hormone	GH	-

Primary Outcome Measures

Name	Time	Method
Change in height, weight, and body composition	6month, 12month, 18month

Secondary Outcome Measures

Name	Time	Method
Changes in total energy expenditure	6month, 12month

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States