Growth Hormone Replacement Therapy for Veterans with mTBI and AGHD
This study is looking at whether growth hormone replacement therapy (Somatropin) can improve the quality of life for veterans who have both adult growth hormone deficiency (AGHD) and a mild traumatic brain injury (mTBI). You might be able to join if you are a veteran aged 21-55, have experienced a mild traumatic brain injury during military service, and have been diagnosed with growth hormone deficiency. Participants will receive either Somatropin or a placebo (an inactive substance) for six months. The main goal is to see if Somatropin improves your quality of life compared to the placebo. The current status of this study is unclear.
- Study design
- This is an interventional study where 172 participants will be randomly assigned to receive either Somatropin or a placebo. Both you and the study team will not know which treatment you are receiving.
- What's involved
- You would receive either Somatropin or a placebo for six months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life will be measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
At a glance
Conditions
Where it's being run
16 sites across 14 statesStudy leadership
- Jose M. Garcia, MD PhD · STUDY_CHAIR · VA Puget Sound Health Care System Seattle Division, Seattle, WA
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)6 months
25 question survey on quality of life; The primary objective of CSP #2018 is to determine the efficacy of rhGH, given daily for 6 months, versus placebo to improve QoL, as measured by difference in mean QoL-AGHDA score, among Veterans with a history of mTBI and AGHD (primary outcome). The primary hypothesis is that the investigators, compared to placebo, patients treated with rhGH will exhibit a 3.5-point lower mean score (higher quality of life) in QoL-AGHDA at 6 months. QoL-AGHDA: minimum score=0 (high QoL: best outcome); maximum score=25 (low QoL: worst outcome).