Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo
Study Overview
Brief 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).
Detailed Description
See below.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 48 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo
Time Frame: 0, 3, 6 months (double-blind phase)
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
Time Frame: 0, 3, 6 months (double-blind phase)
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
Time Frame: 6 months (double-blind phase)
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo
Time Frame: 6 months (double-blind phase)
Secondary Outcomes
- Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)(6, 9, 12 months)
Investigators
Beatrice Golomb
Professor of Medicine
University of California, San Diego