NCT00286689

Effects of Growth Hormone in Chronically Ill Children

Withdrawn NA Last updated 14 December 2018

What this trial tests

NA trial testing Growth Hormone in Hurler Syndrome. Withdrawn.

Timeline

3 February 2006

Primary endpoint
3 February 2006

3 February 2006

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Start date	3 February 2006
Primary completion	3 February 2006
Estimated completion	3 February 2006
Sites	1 location across United States

Drugs / interventions tested

• Growth Hormone — full drug profile →
• Whole body Protein turnover
• DEXA scan

Conditions studied

• Hurler Syndrome — all drugs for Hurler Syndrome →
• Cerebral Palsy — all drugs for Cerebral Palsy →
• Juvenile Rheumatoid Arthritis — all drugs for Juvenile Rheumatoid Arthritis →
• Crohn Disease — all drugs for Crohn Disease →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 3 to 17, any sex, with Hurler Syndrome or Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.