- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00286689
Effects of Growth Hormone in Chronically Ill Children
December 12, 2018 updated by: University of Texas Southwestern Medical Center
The specific aims for this study are -
- 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.
- 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.
- 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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75390
- Children's Medical Center of Dallas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dana S Hardin, MD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 3, 2006
Primary Completion (ACTUAL)
February 3, 2006
Study Completion (ACTUAL)
February 3, 2006
Study Registration Dates
First Submitted
February 1, 2006
First Submitted That Met QC Criteria
February 1, 2006
First Posted (ESTIMATE)
February 3, 2006
Study Record Updates
Last Update Posted (ACTUAL)
December 14, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases
- Brain Damage, Chronic
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Arthritis
- Intestinal Diseases
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Lysosomal Storage Diseases
- Mucinoses
- Inflammatory Bowel Diseases
- Mucopolysaccharidoses
- Cerebral Palsy
- Mucopolysaccharidosis I
- Crohn Disease
- Arthritis, Juvenile
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- 0403-239
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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