Nutrients and Hormones: Effects in Boys With Disordered Growth

October 11, 2011 updated by: Nelly Mauras, Nemours Children's Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrition and Growth Hormone
Drug: Pediasure
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.
Drug: GH
Growth Hormone will be 0.3mg/kg/week, given SC once daily.
Active Comparator: Observation and Growth Hormone
Drug: GH
Growth Hormone will be 0.3mg/kg/week, given SC once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in height, weight, and body composition
Time Frame: 6month, 12month, 18month
6month, 12month, 18month

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in total energy expenditure
Time Frame: 6month, 12month
6month, 12month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 04-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe