Mitochondrial Cocktail for Gulf War Illness (NCT02804828) | Clinical Trial Compass
CompletedNot Applicable
Mitochondrial Cocktail for Gulf War Illness
United States15 participantsStarted 2021-04-09
Plain-language summary
The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).
Who can participate
Age range
48 Years
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:
* Meet symptom criteria for Gulf War illness with BOTH the Centers for Disease Control and Prevention (CDC) Criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and Kansas Criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, GI and respiratory).
Exclusion Criteria:
* Have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for Gulf War illness.
* Participating in a concurrent treatment trial.
* Unwilling or unable to comply with the treatment protocol
* Failed run-in; do not take at least 80% of run-in medications
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 used a 'mitochondrial cocktail' — a combination of supplements including CoQ10 and Vitamin E — to address Gulf War Illness symptoms. Since the trial is now completed, has the results data been published, and what did it show about whether this approach actually helped veterans with my type of symptoms?
2The trial measured physical performance using timed chair rises and tracked up to 20 different Gulf War Illness symptoms. Given my specific symptom profile, do the outcomes they were measuring in this study actually line up with the problems I'm dealing with most, and would that affect whether this approach is worth pursuing for me?
3Since this study tracked blood levels of CoQ10 and Vitamin E alongside symptom changes, do you know if the results showed any connection between changes in those levels and how patients actually felt — and does that tell us anything useful about whether supplementing these nutrients might help in my case?
4This trial is listed as Phase NA, which often applies to supplement or lifestyle studies rather than standard drug trials. What does that mean for how much we can trust the safety and effectiveness findings compared to a traditional Phase 2 or Phase 3 drug trial?
5Are there any standard-of-care treatments or other completed or ongoing studies for Gulf War Illness that you think I should consider alongside or instead of a mitochondrial supplement approach, based on what the evidence currently shows?
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
1
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
Timeframe: 0, 3, 6 months (double-blind phase)
2
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
Timeframe: 6 months (double-blind phase)
3
Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo
Timeframe: 0, 3, 6 months (double-blind phase)
4
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo