Nutrients and Hormones: Effects in Boys With Disordered Growth

Nutrition Disorders Clinical Trial

Official title:

Nutrients and Hormones: Effects in Boys With Disordered Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139451
• Other study ID #: IRB # 04-016
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: October 11, 2011
• Start date: May 2004
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constitutional Growth Delay
• Disease
• Growth Disorders
• Nutrition Disorders
• Puberty, Delayed

Intervention

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

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in height, weight, and body composition		6month, 12month, 18month	No
Secondary	Changes in total energy expenditure		6month, 12month	No

External Links

•   issues related to child health