NCT00286689

Brief Summary

The specific aims for this study are -

  1. 1.To determine the effect of GH on height, height velocity, body weight and lean body mass. This specific aim tests the hypothesis that GH significantly improves height, height velocity, weight, weight velocity and lean body mass in chronically ill children who have grown poorly despite adequate nutritional rehabilitation.
  2. 2.To determine the effect of GH on whole body protein turnover (WBPT), IGF-1 levels and on cytokines. This specific aim tests the hypothesis that chronically ill children have increased catabolism, caused by high levels of circulating cytokines and low levels of IGF-1, and that these abnormalities improve with GH treatment.
  3. 3.Evaluation of bone mineral density and bone turnover. This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine levels.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

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withdrawn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

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

February 3, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2006

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

Same day

First QC Date

February 1, 2006

Last Update Submit

December 12, 2018

Conditions

Hurler SyndromeCerebral PalsyJuvenile Rheumatoid ArthritisCrohn DiseaseHIV Infections

Interventions

Growth HormoneDRUG
Whole body Protein turnoverPROCEDURE
DEXA scanPROCEDURE

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 3-17 years
  • Tanner stages 1-3
  • Each child must have received adequate nutritional therapy supplied by aggressive oral supplementation, gastrostomy tube, or TPN for at least 1 year prior to enrollment.
  • All children will have been referred for continued poor growth and will be less than the 10th percentile for height compared to age and gender normal values.
  • low IGF-1 level at the time of enrollment (measured in the Endocrine clinic).
  • Chronic illness to be included are Hurler Syndrome (MPS-1) with short stature and muscle wasting, cerebral palsy with muscle wasting, juvenile rheumatoid arthritis with muscle wasting and short stature, Crohn's disease and HIV infection.

You may not qualify if:

  • previous diagnosis with diabetes, chronic fevers (temp \> 101.5) or chronic bacterial infection.
  • substantial change in steroid dosing, or having a formerly steroid negative patient start long-term-steroids (anticipated use greater that 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Mucopolysaccharidosis ICerebral PalsyArthritis, JuvenileCrohn DiseaseHIV Infections

Interventions

Growth HormoneAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

MucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesAutoimmune DiseasesImmune System DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

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

    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

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

February 3, 2006

Primary Completion

February 3, 2006

Study Completion

February 3, 2006

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations

US(1)