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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
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: February 2, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

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


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Colonization with Burkholderia cepacia
  • pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00287430

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Dana S Hardin, MD University of Texas, Southwestern Medical Center at Dallas
  More Information Identifier: NCT00287430     History of Changes
Other Study ID Numbers: 0102-035
Study First Received: February 2, 2006
Last Updated: February 2, 2006

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017