Coenzyme Q10 Phase III Trial in Gulf War Illness
Condition: Gulf War Illness; Chronic Fatigue; Ubiquinol; Coenzyme Q10
MeSH terms: Fatigue
Intervention: Ubiquinol; Placebo
Intervention description: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking; Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Intervention MeSH terms: Coenzyme Q10
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Pain; Cognitive Disorders; Inflammation; Neurologic manifestations; Dementia; Mental Disorders; Ubiquinol/ubiquinone; Pathologic Processes; Nervous System Diseases; Hormones, Hormone Substitutes, and Hormone Antagon; Anti-Inflammatory Agents; Pharmacologic Actions; Therapeutic Uses; Physiological Effects of Drugs; Gulf war illness; Chronic fatigue

Summary:

      The primary objective of this clinical trial is to determine if treatment with ubiquinol, a
      form of coenzyme Q10, improves the physical function of men and women Veterans suffering from
      Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short
      Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms.
      Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers
      in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity
      level, and cognitive and mental functioning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Veterans who were deployed in 1990 -1991 Gulf War.

          -  Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War
             Illness.

          -  Veterans who were in good health based on medical history prior to 1990.

          -  Veterans whose severity of illness is moderate to severe, evidenced by scoring less
             than 30 of 100 on the physical domain of SF36.

        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.