Gulf War Syndrome clinical trials at UCSD
3 in progress, 1 open to new patients

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 plus individualized correction of citric acid cycle (CAC) intermediates and amino acid (AA) abnormalities as part of a mitochondrial/oxidative stress treatment approach in Gulf War Illness (GWI).

Goal: The investigators propose to test whether giving the supplement coenzyme Q10 (Q10) improves symptoms and subjective health in Gulf War veterans (GWV) with chronic, multi-symptom health problems. Rationale: Direct empirical evidence, in groups that are not GWV, has supported benefit of Q10 to many of the symptoms that GWV are at heightened risk of experiencing - such as fatigue, muscle pain, and cognition, which are syndrome-defining conditions. In addition, Q10 has also been reported to benefit other symptoms arising at increased rates in GWV, including headaches, sleep disturbances, and breathing problems. This provides a strong rationale for testing whether Q10 will have similar benefit to these symptoms in GWV. Method: 46 GWV with chronic health problems will participate.The design is a randomized, double-blind, placebo-controlled crossover study. Each subject will be "crossed over" between Q10 and an identical placebo, receiving each agent twice, for 3.5 month periods. In one of the Q10 phases, a lower dose of Q10 will be used - 100mg three times a day; while in one a higher dose will be used - 300mg three times a day. Neither subjects nor investigators will know which substance each subject is receiving in which phase. Subjects will be randomly assigned to one of four crossover orders. Assessments: Assessments will include subjective quality of life; symptoms that are "syndrome defining" for Gulf War illness (like fatigue and muscle problems); and other symptoms and conditions reported to occur more commonly in GWV (like sleep problems). Analyses will show whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses; and whether people with certain symptoms or characteristics get more benefit than people with other symptoms or characteristics.