Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Growth Hormone in Chronically Ill Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00286689
First received: February 1, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286689

Locations
United States, Texas
Children’s Medical Center of Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286689     History of Changes
Other Study ID Numbers: 0403-239
Study First Received: February 1, 2006
Last Updated: February 1, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Arthritis, Juvenile
Arthritis, Rheumatoid
Cachexia
Cerebral Palsy
Crohn Disease
Dwarfism
HIV Infections
Muscular Atrophy
Arthritis
Atrophy
Autoimmune Diseases
Body Weight
Body Weight Changes
Bone Diseases
Bone Diseases, Developmental
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Connective Tissue Diseases
Digestive System Diseases
Emaciation
Endocrine System Diseases
Gastroenteritis
Gastrointestinal Diseases
Genetic Diseases, Inborn
Immune System Diseases
Immunologic Deficiency Syndromes
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 19, 2014