CoQ10 in Gulf War Illness

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Coenzyme Q10; Ubiquinone

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.