Coenzyme Q10 for Gulf War Illness: A Replication Study
NCT Number: NCT06515184
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Gulf War Syndrome|Persian Gulf Syndrome|Mitochondrial Disorder, Respiratory Chain
Interventions: DRUG: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg|DRUG: PharmaNord Placebo|DRUG: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
Sponsor: University of California, San Diego
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-12
Locations: UC San Diego, La Jolla, California, 92093, United States

Summary:
The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.

Primary Outcome Measures: Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo., All outcomes are assessed as change from baseline., 3.5-4 months
Secondary Outcome Measures: Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score., All outcomes are assessed as change from baseline., 3.5-4 months|Mean change in single-item General Self-Rated Health (GSRH)., All outcomes are assessed as change from baseline. 5 point scale, higher is good., 3.5-4 months|Individual GWI Symptoms, 7 validated single-item symptom self-ratings: headache; energy; fatigue with exertion, muscle pain; irritability; impatience; trouble recalling words/names. Each benefited with coQ10, p\<0.05 (two-sided), in the prior coQ10 trial., 3.5-7 months (From primary endpoint phase to the seven month phase, quadruple blinding is retained for the coQ10 dose, but all parties are aware that this phase involves only active treatment.)|Relation of change in time to do five chair rises to change in blood level of coenzyme Q10, Benefit to timed chair rises will relate to blood coQ10 change. This outcome assesses the relation between change in time to complete five chair rises (in seconds) to change in blood level of CoQ10 (in ug/mL). The prediction of change in time to perform five chair rises by change in coQ10 blood level (regression with robust standard errors)., 3.5-7 months (From primary endpoint phase to the seven month phase, quadruple blinding is retained for the coQ10 dose, but all parties are aware that this phase involves only active treatment.)|Effect of CoQ10 in the majority male subset on symptoms., Change in symptoms on coQ10 versus placebo will be assessed in men (male subset of sample)., 3.5-7 months (From primary endpoint phase to the seven month phase, quadruple blinding is retained for the coQ10 dose, but all parties are aware that this phase involves only active treatment.)|Effect of CoQ10 in the majority male subset on timed chair rises., Change in timed chair rises on coQ10 versus placebo will be assessed in men (male subset of sample)., 3.5-7 months (From primary endpoint phase to the seven month phase, quadruple blinding is retained for the coQ10 dose, but all parties are aware that this phase involves only active treatment.)|Effect of CoQ10 in the majority male subset on GSRH., Change in GSRH on coQ10 versus placebo will be assessed in men (male subset of sample)., 3.5-7 months (From primary endpoint phase to the seven month phase, quadruple blinding is retained for the coQ10 dose, but all parties are aware that this phase involves only active treatment.)
Other Outcome Measures: The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on symptoms., Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on symptoms., 3.5, 7 months|The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on timed chair rises., Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on timed chair rises., 3.5, 7 months|The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on GSRH., Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on GSRH., 3.5, 7 months|Duration Effect on symptoms. Compare effects of 7 months vs 3.5 months of treatment, assessed at the same time point after baseline (7 months) on symptoms., Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months)., 7 months|Duration Effect on timed chair rises. Compare effects of 7 months vs 3.5 months of treatment, assessed at the same time point after baseline (7 months) on timed chair rises., Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months)., 7 months|Duration Effect on GSRH. Compare effects of 7 months vs 3.5 months of treatment, assessed at the same time point after baseline (7 months) on GSRH., Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months)., 7 months|Blood Pressure, Specifically, change in blood pressure on coq10 versus placebo will be assessed considering those with low blood pressure at baseline separately from those with borderline or high blood pressure at baseline., 3.5, 7 months|Mitochondrial Function from blood spot card. Maximal respiration will be assessed by the "adopted transfer" technique., 3.5, 7 months|Mitochondrial Function from blood spot card. Spare capacity will be assessed by the "adopted transfer" technique., 3.5, 7 months|Inflammation (hsCRP) will be assessed as change from baseline and compared on active treatment vs. placebo., 3.5, 7 months|Oxidative Stress (oxidized LDL), 3.5, 7 months|Liver Function. Alanine aminotransferase and aspartate aminotransferase will be assessed as change from baseline and compared on active treatment vs. placebo., 3.5, 7 months|Dropouts for Cause. The investigator will report participants who drop out for a reason., For instance, participants who transition from coQ10 to placebo might drop because of lost of needed benefits of coQ10 -- because the participant felt worse. Alternatively, participants who transition from placebo run-in to coQ10 might drop out due to problems like activation of insomnia on active treatment. The number of dropouts will be compared on active treatment vs placebo, and the causes of dropout will be compared also. (Participants who drop because their physicians ask them to do so for some unrelated reason, not because the patient has had a problem or perceive a problem, will count as dropouts, but not as dropouts for "cause" -- cause here refers to a symptom change and/or medical event.), 3.5 months