Mitochondrial Cocktail for Gulf War Illness

Study Overview
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Brief Summary
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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
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See below.

Official Title
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Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness

Conditions
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Gulf War Syndrome, Persian Gulf Syndrome, Mitochondrial Disorders

Intervention / Treatment
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* Dietary Supplement: Individualized mitochondrial cocktail
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Design study is followed by Crossover to open label treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Dietary Supplement: Individualized mitochondrial cocktail<br>* 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).<br>|
| Sham Comparator: Arm 2<br> | Dietary Supplement: Placebo<br>* 6 months for the double-blind phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo |  | 6 months (double-blind phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) | 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). | 6, 9, 12 months |