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Nutrients and Hormones: Effects in Boys With Disordered Growth

NCT00139451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-10-12

No results posted yet for this study

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.

Conditions

  • Constitutional Growth Delay
  • Nutrition Disorders
  • Growth Disorders

Interventions

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-12-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00139451 on ClinicalTrials.gov