Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis
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|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Recruitment Status : Withdrawn (D Hardin not at institution, IRB has no record, no other investigators for study information)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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- 1) body weight
- 2) lean body mass.
- 1) whole body protein turnover
- 2) hepatic glucose production
- 3) bone mineral density
- 4) pulmonary function status
- 5) quality of life
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
|Principal Investigator:||Dana S Hardin, MD||University of Texas, Southwestern Medical Center at Dallas|