At a glance
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Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
In Brief
A Phase 4 clinical trial evaluating Recombinant human growth hormone for Growth Hormone Deficiency and Traumatic Brain Injury. Completed, enrolled 15 participants across 2 sites.
Detailed 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).
Study Details
Timeline
Interventions
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)