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Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)

Study acronym: GWIT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 2026 to Dec 2026 Completion date: Jul 2026 to Jul 1, 2027v9 Show 1 more changeShow less
    • Completion date: Jul 2026 to Jul 1, 2027
  2. Primary completion date: May 2025 to Jul 2026 Completion date: Sep 2025 to Jul 2026 · Start date: Feb 12, 2024 to Mar 11, 2024v8 Show 2 more changesShow less
    • Completion date: Sep 2025 to Jul 2026
    • Start date: Feb 12, 2024 to Mar 11, 2024
  3. Re-verified, no change to tracked fieldsv7
  4. Start date changed from estimate of Jan 11, 2024 to Feb 12, 2024v6
  5. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 36 to 20 · Start date: Dec 1, 2023 to Jan 11, 2024 · Interventions: Placebo (Drug), Recombinant human growth hormone (Drug) to Recombinant human growth hormone (Drug) · 4 morev5 Show 7 more changesShow less
    • Enrollment target: 36 to 20
    • Start date: Dec 1, 2023 to Jan 11, 2024
    • Interventions: Placebo (Drug), Recombinant human growth hormone (Drug) to Recombinant human growth hormone (Drug)
    • Site details revised at 2 of 2 sites
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jun 2023 to Dec 1, 2023v4
  2. Primary completion date: May 2024 to May 2025 Completion date: Sep 2024 to Sep 2025 · Study title expanded, about 1 wordv3 Show 2 more changesShow less
    • Completion date: Sep 2024 to Sep 2025
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Aug 2022 to Jun 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of the GWIT Study is to assess whether growth hormone replacement therapy is a safe and effective treatment for veterans with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). The main questions the study aims to answer are: 1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency? 2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness? To determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial.
Trial Details
NCT Number NCT05355272
Lead Sponsor Baylor College of Medicine
Collaborators: United States Department of Defense
Conditions Gulf War Syndrome, Adult Growth Hormone Deficiency
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov