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Growth Hormone and Chromosome 18q- and Abnormal Growth

NCT00134420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-08

No results posted yet for this study

Summary

We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.

Conditions

  • Loss of Chromosome 18q
  • Growth Hormone Deficiency

Interventions

DRUG

Nutropin AQ

Growth Hormone (Nutropin AQ) treatment given to Group 1 immediately Growth Hormone (Nutropin AQ) treatment given to Group 2 after one year observation

PROCEDURE

Arginine and Clonidine Stimulation Testing

This testing was done to determine growth hormone status prior to starting treatment.

PROCEDURE

Growth Factors Laboratory Testing

This involved assessment of growth factors such as IGF#1 before treatment was initiated.

PROCEDURE

Neuropsychological Testing

This testing was done prior to treatment and at the end of treatment.

Sponsors & Collaborators

  • South Texas Veterans Health Care System

    collaborator FED

  • Genentech, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Daniel E. Hale, M.D. · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134420 on ClinicalTrials.gov