Nutrients and Hormones: Effects in Boys With Disordered Growth

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00139451
First received: August 29, 2005
Last updated: October 11, 2011
Last verified: October 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutrients and Hormones: Effects in Boys With Disordered Growth

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in height, weight, and body composition [ Time Frame: 6month, 12month, 18month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in total energy expenditure [ Time Frame: 6month, 12month ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2004
Study Completion Date: September 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Nelly Mauras, Chief, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00139451     History of Changes
Other Study ID Numbers: IRB # 04-016
Study First Received: August 29, 2005
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
GH
Delayed Growth
Energy Expenditure
Puberty
Nutrition
Short Stature

Additional relevant MeSH terms:
Growth Disorders
Nutrition Disorders
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014