Coenzyme Q10 Phase III Trial in Gulf War Illness
CompletedPhase 3NCT02865460
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
- Conditions
- Gulf War Illness
- Chronic Fatigue
- Ubiquinol
- Coenzyme Q10
- Interventions
- Drug: Ubiquinol
- Drug: Placebo
- Sponsor
- VA Office of Research and Development
- Start date
- 2017-07-24
- Primary completion
- 2020-10-07
- Sex
- All
- Age range
- from 35 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02865460