Skip to main content
OpenTrials
Completed

NCT Number: NCT00139451

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constitutional Growth Delay Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Gonadal Disorders Growth Disorders Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Puberty, Delayed

Age range

7 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediasure

Drug

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.

GH

Drug

Growth Hormone will be 0.3mg/kg/week, given SC once daily.

Primary outcomes

  1. Change in height, weight, and body composition

    Time frame: 6month, 12month, 18month

Secondary outcomes

  1. Changes in total energy expenditure

    Time frame: 6month, 12month

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2010
First posted
Aug 31, 2005
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.