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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
History of Changes

August 29, 2005
October 11, 2011
May 2004
December 2007   (final data collection date for primary outcome measure)
Change in height, weight, and body composition [ Time Frame: 6month, 12month, 18month ] [ Designated as safety issue: No ]
change in height,weight,body composition, energy usage.
Complete list of historical versions of study NCT00139451 on ClinicalTrials.gov Archive Site
Changes in total energy expenditure [ Time Frame: 6month, 12month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Nutrients and Hormones: Effects in Boys With Disordered Growth
Nutrients and Hormones: Effects in Boys With Disordered Growth

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Constitutional Growth Delay
  • Nutrition Disorders
  • Growth Disorders
  • 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: Nutrition and Growth Hormone
    Interventions:
    • Drug: Pediasure
    • Drug: GH
  • Active Comparator: Observation and Growth Hormone
    Intervention: Drug: GH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
December 2007   (final data collection date for primary outcome measure)

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
Male
7 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139451
IRB # 04-016
No
Nelly Mauras, Nemours Children's Clinic
Nemours Children's Clinic
Genentech
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic
Nemours Children's Clinic
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP