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Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287430
First Posted: February 6, 2006
Last Update Posted: February 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose

We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of patients with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life.

We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own control by obtaining medical records for 6 months to 1 year prior to study enrollment or by completing 6 months of study without GH prior to being treated for 1 yr. with GH.


Condition Intervention
Cystic Fibrosis Drug: Growth Hormone Procedure: Whole body Protein Turnover Study Procedure: Dual Energy X-ray Absorptiometry (DEXA)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 1) body weight
  • 2) lean body mass.

Secondary Outcome Measures:
  • 1) whole body protein turnover
  • 2) hepatic glucose production
  • 3) bone mineral density
  • 4) pulmonary function status
  • 5) quality of life

Estimated Enrollment: 12
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 - 40 years
  • less than 100% of ideal body weight.

Exclusion Criteria:

  • Colonization with Burkholderia cepacia
  • pregnancy.
  Contacts and Locations
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): NCT00287430


Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Dana S Hardin, MD University of Texas, Southwestern Medical Center at Dallas
  More Information

ClinicalTrials.gov Identifier: NCT00287430     History of Changes
Other Study ID Numbers: 0102-035
First Submitted: February 2, 2006
First Posted: February 6, 2006
Last Update Posted: February 6, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs