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Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

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.
 
ClinicalTrials.gov Identifier: NCT00287430
Recruitment Status : Withdrawn (D Hardin not at institution, IRB has no record, no other investigators for study information)
First Posted : February 6, 2006
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Dana S Hardin
Information provided by (Responsible Party):
Nancy Rollins, University of Texas Southwestern Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Growth Hormone Procedure: Whole body Protein Turnover Study Procedure: Dual Energy X-ray Absorptiometry (DEXA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2006
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

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

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


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.

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
Dana S Hardin
Investigators
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Principal Investigator: Dana S Hardin, MD University of Texas, Southwestern Medical Center at Dallas
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Responsible Party: Nancy Rollins, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00287430    
Other Study ID Numbers: 0102-035
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Cystic Fibrosis
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