NCT00287430

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

February 2, 2006

Last Update Submit

March 8, 2019

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

  • 1) body weight

  • 2) lean body mass.

Secondary Outcomes (5)

  • 1) whole body protein turnover

  • 2) hepatic glucose production

  • 3) bone mineral density

  • 4) pulmonary function status

  • 5) quality of life

Interventions

Growth HormoneDRUG
Whole body Protein Turnover StudyPROCEDURE
Dual Energy X-ray Absorptiometry (DEXA)PROCEDURE

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Colonization with Burkholderia cepacia
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Growth HormoneAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Dana S Hardin, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 6, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

March 12, 2019

Record last verified: 2019-03