Effects of Growth Hormone in Chronically Ill Children
|ClinicalTrials.gov Identifier: NCT00286689|
Recruitment Status : Unknown
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|- 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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286689
|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|