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).
See below.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
15
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).
6 months for the double-blind phase
UC San Diego
La Jolla, California, United States
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)
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 of CoQ10 and Vitamin E levels, comparing active treatment to placebo
Time frame: 6 months (double-blind phase)
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).
Time frame: 6, 9, 12 months
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