NCT00957671

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

Detailed description

This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

Conditions

• Growth Hormone Deficiency
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Recombinant human growth hormone	200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)

Timeline

• Start date: 2003-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2009-08-12
• Last updated: 2018-06-29
• Results posted: 2018-05-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study