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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00286689 |
The specific aims for this study are –
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 |
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- 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 18 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Children’s Medical Center of Dallas | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Dana S Hardin, MD | University of Texas Southwestern Medical Center |
Study ID Numbers: | 0403-239 |
Study First Received: | February 1, 2006 |
Last Updated: | February 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00286689 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pathological Conditions, Anatomical Crohn's Disease Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Hormone Antagonists Brain Damage, Chronic Hormones, Hormone Substitutes, and Hormone Antagonists Arthritis, Rheumatoid Inflammatory Bowel Diseases Brain Diseases Hormones Ileal Diseases Metabolism, Inborn Errors Signs and Symptoms Mucopolysaccharidoses |
Cerebral Palsy Musculoskeletal Diseases Arthritis Connective Tissue Diseases Brain Injuries Metabolic Disorder Retroviridae Infections Muscular Atrophy Metabolic Diseases Arthritis, Juvenile Rheumatoid Autoimmune Diseases Ileitis Lysosomal Storage Diseases Enteritis Joint Diseases |
Pathological Conditions, Anatomical Slow Virus Diseases Physiological Effects of Drugs Brain Damage, Chronic Arthritis, Rheumatoid Hormones, Hormone Substitutes, and Hormone Antagonists Brain Diseases Mucinoses Ileal Diseases Hormones Metabolism, Inborn Errors Mucopolysaccharidoses Cerebral Palsy Muscular Atrophy Neuromuscular Manifestations |
Arthritis, Juvenile Rheumatoid Metabolic Diseases Immune System Diseases Ileitis Lysosomal Storage Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Virus Diseases HIV Infections Atrophy Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Inflammatory Bowel Diseases Signs and Symptoms Musculoskeletal Diseases |