Gulf War Syndrome, Mitochondrial Disorders, Persian Gulf Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTIndividualized mitochondrial cocktail
Nutrient cocktail comprising: thiamine, nicotinamide, pantothenic acid, riboflavin, L-carnitine, alpha lipoic acid, CoQ10, vitamin C, vitamin E, and omega 3 fatty acids (Cod Liver Oil).
DIETARY_SUPPLEMENTPlacebo
6 months for the double-blind phase
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Design study is followed by Crossover to open label treatment.
Eligibility
Sex/Gender
ALL
Age
48 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo | 6 months (double-blind phase) |
| Mean change in single item General Self-Rated Health Visual Analog Scale from baseline | 0, 3, 6 months (double-blind phase) |
| Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises | 6 months (double-blind phase) |
| Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo | 0, 3, 6 months (double-blind phase) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) | 6, 9, 12 months | Secondary measures will incorporate assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) at primary endpoint time point. We will assess at additional time points (9, 12 month) and will assess effects stratified by sex; by dominant ethnicity; and by use of medications that can affect levels or disposition of supplement components (e.g. statin use). |
Countries
United States
Outcome results
None listed