Coenzyme Q10 for Gulf War Illness: A Replication Study
- Conditions
- Mitochondrial Disorder, Respiratory ChainGulf War SyndromePersian Gulf Syndrome
- Interventions
- Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mgDrug: PharmaNord Placebo
- Registration Number
- NCT06515184
- Lead Sponsor
- University of California, San Diego
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- Meets both CDC and Kansas deployment and symptom inclusion criteria.
- Does not have a disqualifying condition.
- Able to travel to a local Quest facility for study blood draws.
- Adequate internet access to allow ZoomPro visit participation and remote survey completion.
- Health prior to the Gulf War rated as "very good" or "excellent" (to exclude persons who may have had other health conditions with different mechanisms as the cause of their symptoms).
- Willing to defer initiation of discretionary treatments or supplements during the expected course of study participation.
- Participating in another clinical trial.
- Still-evolving adverse effects following another medication or health condition, such as covid or fluoroquinolone use.
- On Coumadin/ warfarin.
- Unable to participate for the required duration of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CoQ10 Arm 2 PharmaNord Bio-Quinone Active CoQ10 Gold 100mg PharmaNord Ubiquinone 100mg/3x day Placebo Arm PharmaNord Placebo Placebo (made by PharmaNord, matches active treatment) CoQ10 Arm 1 PharmaNord Bio-Quinone Active CoQ10 Gold 100mg PharmaNord Ubiquinone 100mg/1x day
- Primary Outcome Measures
Name Time Method Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo. 3.5 months All outcomes are assessed as change from baseline.
- Secondary Outcome Measures
Name Time Method Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score. 3.5 months All outcomes are assessed as change from baseline.
Mean change in single-item General Self-Rated Health (GSRH). 3.5 months All outcomes are assessed as change from baseline. 5 point scale, higher is good.
Individual GWI Symptoms 3.5, 7 months 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.
Relation of change in time to do five chair rises to change in blood level of coenzyme Q10 3.5, 7 months 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).
Effect of CoQ10 in the majority male subset on symptoms. 3.5, 7 months Change in symptoms on coQ10 versus placebo will be assessed in men (male subset of sample).
Effect of CoQ10 in the majority male subset on timed chair rises. 3.5, 7 months Change in timed chair rises on coQ10 versus placebo will be assessed in men (male subset of sample).
Effect of CoQ10 in the majority male subset on GSRH. 3.5, 7 months Change in GSRH on coQ10 versus placebo will be assessed in men (male subset of sample).
Trial Locations
- Locations (1)
UC San Diego
🇺🇸La Jolla, California, United States