Clinical trial NCT06515184: Coenzyme Q10 for Gulf War Illness: A Replication Study
Official title: Coenzyme Q10 for Gulf War Illness: A Replication Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gulf War Syndrome
Persian Gulf Syndrome
Mitochondrial Disorder, Respiratory Chain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-07-23
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Design (primary) is followed by active treatment phase (still blind to dose).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 3.5 months
Secondary outcomes:
measure: Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.
timeFrame: 3.5 months
measure: Mean change in single-item General Self-Rated Health (GSRH).
timeFrame: 3.5 months
measure: Individual GWI Symptoms
timeFrame: 3.5, 7 months
measure: Relation of change in time to do five chair rises to change in blood level of coenzyme Q10
timeFrame: 3.5, 7 months
measure: Effect of CoQ10 in the majority male subset on symptoms.
timeFrame: 3.5, 7 months
measure: Effect of CoQ10 in the majority male subset on timed chair rises.
timeFrame: 3.5, 7 months
measure: Effect of CoQ10 in the majority male subset on GSRH.
timeFrame: 3.5, 7 months
Other outcomes:
measure: The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on symptoms.
timeFrame: 3.5, 7 months
measure: The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on timed chair rises.
timeFrame: 3.5, 7 months
measure: The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on GSRH.
timeFrame: 3.5, 7 months
measure: 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.
timeFrame: 7 months
measure: 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.
timeFrame: 7 months
measure: 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.
timeFrame: 7 months
measure: Blood Pressure
timeFrame: 3.5, 7 months
measure: Mitochondrial Function from blood spot card. Maximal respiration will be assessed by the "adopted transfer" technique.
timeFrame: 3.5, 7 months
measure: Mitochondrial Function from blood spot card. Spare capacity will be assessed by the "adopted transfer" technique.
timeFrame: 3.5, 7 months
measure: Inflammation (hsCRP) will be assessed as change from baseline and compared on active treatment vs. placebo.
timeFrame: 3.5, 7 months
measure: Oxidative Stress
timeFrame: 3.5, 7 months
measure: Liver Function. Alanine aminotransferase and aspartate aminotransferase will be assessed as change from baseline and compared on active treatment vs. placebo.
timeFrame: 3.5, 7 months
measure: Dropouts for Cause. The investigator will report participants who drop out for a reason.
timeFrame: 3.5, 7 months
measure: Relation of change in symptoms to change in blood level of coenzyme Q10
timeFrame: 3.5 +/- 0.5 months (priority), and ~7 months
measure: Relation of change in single-item General Self-Rated Health (GSRH) to change in blood level of coenzyme Q10
timeFrame: 3.5, 7 months
measure: Subset effects in those citing prior coQ10 use, stratified by whether benefit had been perceived.
timeFrame: 3.5, 7 months
measure: Analysis stratified by presence of symptoms compatible with sleep apnea
timeFrame: 3.5, 7 months
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Beatrice A Golomb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: