Nutrients and Hormones: Effects in Boys With Disordered Growth - Full Text View

Sponsors and Collaborators:	Nemours Children's Clinic Genentech
Information provided by:	Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT00139451

Purpose

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
Constitutional Growth Delay Nutrition Disorders Growth Disorders	Drug: Pediasure Drug: GH	Phase II

MedlinePlus related topics: Growth Disorders

U.S. FDA Resources

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

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:

Change in height, weight, and body composition

Secondary Outcome Measures:

Changes in total energy expenditure

Estimated Enrollment:	20
Study Start Date:	May 2004
Estimated Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	7 Years to 10 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139451

Locations

United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207

Sponsors and Collaborators

Nemours Children's Clinic

Genentech

Investigators

Principal Investigator:

Nelly Mauras, MD

Nemours Children's Clinic

More Information

issues related to child health This link exits the ClinicalTrials.gov site

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

Keywords provided by Nemours Children's Clinic:

GH
Delayed Growth
Energy Expenditure

Puberty
Nutrition
Short Stature

Study placed in the following topic categories:

Growth Disorders
Nutrition Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009