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Effects of Growth Hormone in Chronically Ill Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: February 1, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

The specific aims for this study are –

  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. 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. 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.

We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and weight of chronically ill children who have failed to grow despite receiving adequate nutrition via gastrostomy tube or oral supplementation.

Condition Intervention
- 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 - HIV Infection. Drug: Growth Hormone Procedure: Whole body Protein turnover Procedure: DEXA scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 18
Detailed Description:
We will test our hypotheses by using a pilot study, in which we will recruit 18 chronically ill children from our clinical practice. We will obtain medical records for each patient 12 months prior to starting the study. Those patients without pre-study medical records will be studied for 12 months prior to starting GH. If we can obtain 6 months of prior medical records, then the patients will be studied for 6 months before starting GH. Anything less than 6 months will be studied for the full 12 months prior to starting GH. Patients will receive treatment with GH (0.3 mg/kg/wk) for 12 months and their growth will be compared to the year before treatment. All subjects will be followed every three months for the entire study. We will measure height and weight using a standardized stadiometer and scale, respectively, every three months during the study. From these measurements we will calculate height and weight velocity and height and weight Z score. Lean body mass (LBM) will be measured by DEXA every six months. Utilizing the stable isotope 1-[13C] leucine, we will measure whole body protein turnover (WBPT). Measurements of WBPT will be correlated with LBM and changes in height and weight velocity. This data will be compared to that from age matched normal children (archival data maintained by the PI). We will measure IGF-1 and the cytokines TNF-α, IL-6 and IL 10 at baseline and very six months. We will evaluate GH effects on these levels.

Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00286689

United States, Texas
Children’s Medical Center of Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center
  More Information Identifier: NCT00286689     History of Changes
Other Study ID Numbers: 0403-239
Study First Received: February 1, 2006
Last Updated: February 1, 2006

Additional relevant MeSH terms:
Arthritis, Rheumatoid
HIV Infections
Crohn Disease
Cerebral Palsy
Wasting Syndrome
Arthritis, Juvenile
Muscular Atrophy
Mucopolysaccharidosis I
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Brain Damage, Chronic processed this record on September 21, 2017