Coenzyme Q10 Phase III Trial in Gulf War Illness
Condition: Gulf War Illness; Chronic Fatigue; Ubiquinol; Coenzyme Q10
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and
      Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are
      suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by
      multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be
      oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction
      Exploratory studies using interventions that support cell functioning and prevent or repair
      stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The
      goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing
      physical functioning for Veterans with Gulf War Illness.

      This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial.
      The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a
      day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for
      2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome
      measure for this clinical trial is a change from baseline of SF-36, with respect to physical
      functioning and symptoms. The secondary outcome measures include changes from baseline of
      peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain,
      fatigue, sleep issues, and cognitive impairment.
    

Intervention name(s): Ubiquinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Coenzyme Q10, CoQ10; Sugar pill, inactive substance
Intervention MeSH terms: Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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