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Nutrients and Hormones: Effects in Boys With Disordered Growth

Primary Purpose

Constitutional Growth Delay, Nutrition Disorders, Growth Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pediasure
GH
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constitutional Growth Delay focused on measuring GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature

Eligibility Criteria

7 Years - 10 Years (Child)MaleDoes not accept healthy 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

Sites / Locations

  • Nemours Children's Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nutrition and Growth Hormone

Observation and Growth Hormone

Arm Description

Outcomes

Primary Outcome Measures

Change in height, weight, and body composition

Secondary Outcome Measures

Changes in total energy expenditure

Full Information

First Posted
August 29, 2005
Last Updated
October 11, 2011
Sponsor
Nemours Children's Clinic
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00139451
Brief Title
Nutrients and Hormones: Effects in Boys With Disordered Growth
Official Title
Nutrients and Hormones: Effects in Boys With Disordered Growth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constitutional Growth Delay, Nutrition Disorders, Growth Disorders
Keywords
GH, Delayed Growth, Energy Expenditure, Puberty, Nutrition, Short Stature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition and Growth Hormone
Arm Type
Active Comparator
Arm Title
Observation and Growth Hormone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pediasure
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GH
Intervention Description
Growth Hormone will be 0.3mg/kg/week, given SC once daily.
Primary Outcome Measure Information:
Title
Change in height, weight, and body composition
Time Frame
6month, 12month, 18month
Secondary Outcome Measure Information:
Title
Changes in total energy expenditure
Time Frame
6month, 12month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly Mauras, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Links:
URL
http://kidshealth.org
Description
issues related to child health

Learn more about this trial

Nutrients and Hormones: Effects in Boys With Disordered Growth

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