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Nutrients and Hormones: Effects in Boys With Disordered Growth

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ClinicalTrials.gov Identifier: NCT00139451
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Constitutional Growth Delay Nutrition Disorders Growth Disorders Drug: Pediasure Drug: GH Phase 2

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutrients and Hormones: Effects in Boys With Disordered Growth
Study Start Date : May 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. Change in height, weight, and body composition [ Time Frame: 6month, 12month, 18month ]

Secondary Outcome Measures :
  1. Changes in total energy expenditure [ Time Frame: 6month, 12month ]


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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139451


Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Genentech, Inc.
Investigators
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic

Additional Information:
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
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Disease
Nutrition Disorders
Growth Disorders
Puberty, Delayed
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs