Nutrients and Hormones: Effects in Boys With Disordered Growth

NCT00139451 | Completed Phase 2

• 1 other identifier: IRB # 04-016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Constitutional Growth Delay; Nutrition Disorders; Growth Disorders

Keywords

GH; Delayed Growth; Energy Expenditure; Puberty; Nutrition; Short Stature

Outcome Measures

Primary Outcomes (1)

• Change in height, weight, and body composition

  6month, 12month, 18month

Secondary Outcomes (1)

• Changes in total energy expenditure

  6month, 12month

Study Arms (2)

Nutrition and Growth Hormone

ACTIVE COMPARATOR

Drug: Pediasure; Drug: GH

Observation and Growth Hormone

ACTIVE COMPARATOR

Drug: GH

Interventions

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.

Nutrition and Growth Hormone

GH DRUG

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

Nutrition and Growth Hormone; Observation and Growth Hormone

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
• Delay in skeletal maturation \> 1 year.

You may not qualify if:

• Growth hormone deficiency
• Chronic illness
• Participation in high endurance athletics

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Links

• issues related to child health

MeSH Terms

Conditions

Puberty, Delayed; Nutrition Disorders; Growth Disorders; Dwarfism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nelly Mauras, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Endocrinology, Diabetes & Metabolism

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: May 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)