Coenzyme Q10 Phase III Trial in Gulf War Illness

Exclusion Criteria

• •Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:
• •* severe psychiatric problems
• •* schizophrenia
• •* bipolar disorder
• •* major depression with psychotic or melancholic features
• •* delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.
• •* Has dementias of any type
• •* Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).
• •* Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.
• •Medical conditions excluded:
• •* organ failure
• •* defined rheumatologic inflammatory disorders
• •* chronic active infections such as HIV, hepatitis B and C, or transplant
• •* primary sleep disorders
• •Medications that could potentially impact immune function excluded:
• •* steroids
• •* immune-suppressives
• •* nutraceuticals that are formulated to impact mitochondrial function or oxidative stress
• •* Biologic response modifiers within 3 months of study entry.
• •Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
• •Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
• •Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.
• •Common multivitamin preparations will be allowed if taken without change throughout the protocol.