CompletedPhase 2

Gulf War Illness Inflammation Reduction Trial

United States83 participantsStarted 2015-07

Plain-language summary

The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case Definition * Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2, 1990-July 31, 1991) Exclusion Criteria: * Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD * Known hypersensitivity to Prednisone * Liver, (active or recent Hepatitis B or C treatment with a completion date within the past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6 months of treatment) * Treated Diabetes * Females who are Pregnant or Nursing * Female who refuses to use an accepted method of birth control * Exclusionary Labs: C-Reactive Protein \>25, Creatinine Clearance \<30, EFGR ≥ 30, Hgb A1-C \>7, Glucose \>120, WBC \>12, RBC \>6.2, Hematocrit \>60, Hemoglobin \<11, Platelets \<100, Liver Function Tests (2 x the upper limit of AST and ALT, 2 x the upper limit of Total Bilirubin, and Alkaline Phosphatase) * Has Inflammatory Arthritis (RA, or Psoriatic Arthritis, Spondylitis, Polyarthritis) * Reactive Arthritis, or IBD associated Arthritis * Has any major inflammatory disease (acute Chronic Infections, Ulcerative Colitis, Crohn's Disease, Inflammatory lung diseases- COPD or Asthma requiring steroid treatment, Pericarditis, Vasculitis) * Has an chronic/active infection * Chronic use of Prednisone or Corticosteroids (occasional inhaled use of steroids acceptable) * Active Gum Disease or Dental Infecti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial specifically targeted Gulf War Illness symptoms like chronic pain, fatigue, and cognitive impairment — do my symptoms match closely enough that the findings from this trial might be relevant to my care?
2Since this was a Phase 2 trial, what does that mean for how confident we can be in the safety and effectiveness of whatever treatment was being tested, and are there larger follow-up studies I should know about?
3The trial measured physical health improvements at 8 and 16 weeks using a standardized veterans' survey — did the results show meaningful real-world improvements in those areas, or were the changes modest?
4Are there any treatments that came out of this trial's findings that are now available to me outside of a research setting, or would I need to look for a follow-on trial to access them?
5Given that this trial is now completed and focused on inflammation as a driver of Gulf War Illness, is testing or treating for chronic inflammation something we should be exploring as part of my current care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks

Timeframe: 0, 8, and 16 weeks

Trial details

NCT IDNCT02506192

SponsorMinneapolis Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-10-19

Results submitted2023-10-19

View on ClinicalTrials.gov More Chronic Inflammation trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.