Coenzyme Q10 for Gulf War Illness: A Replication Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gulf War Syndrome; Persian Gulf Syndrome; Mitochondrial Disorder, Respiratory Chain
• Intervention / Treatment: Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Drug: PharmaNord Placebo

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Janis B Ritchie, BSN; Phone Number: 858-558-4950; Email: jbritchie@ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UC San Diego
      • Contact: Janis B. Ritchie, BSN; Phone Number: 203 858-558-4950; Email: golombresearch@ucsd.edu
      • Principal Investigator: Beatrice A. Golomb, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CoQ10 Arm 1; PharmaNord Ubiquinone 100mg/1x day	Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Each participant receives one softgel three times a day. Arm 1 receives one 100mg softgel and two placebo softgels per day. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.; Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Each participant receives one softgel three times a day. Arm 2 receives three 100mg softgels per day. Supplement is taken orally in divided doses, with the last softgel not close to bedtime. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.
Active Comparator: CoQ10 Arm 2; PharmaNord Ubiquinone 100mg/3x day	Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Each participant receives one softgel three times a day. Arm 1 receives one 100mg softgel and two placebo softgels per day. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.; Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg; Each participant receives one softgel three times a day. Arm 2 receives three 100mg softgels per day. Supplement is taken orally in divided doses, with the last softgel not close to bedtime. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.
Placebo Comparator: Placebo Arm; Placebo (made by PharmaNord, matches active treatment)	Drug: PharmaNord Placebo; Each participant receives one softgel three times a day. Arm 3 receives three placebo softgels per day. Supplement is taken orally in divided doses, with the last softgel not close to bedtime. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	All outcomes are assessed as change from baseline.	3.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Oxidative Stress		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 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.) In addition to overall assessment, assessment of dropouts for cause will be evaluated stratified by whether the participant is transitioning from coQ10.	3.5, 7 months
Relation of change in symptoms to change in blood level of coenzyme Q10	This outcome assesses the relation between change in symptoms to change in blood level of CoQ10 (in ug/mL).	3.5 +/- 0.5 months (priority), and ~7 months
Relation of change in single-item General Self-Rated Health (GSRH) to change in blood level of coenzyme Q10	This outcome assesses the relation between change in single-item General Self-Rated Health (GSRH) to change in blood level of CoQ10 (in ug/mL). The GSRH is a 5 point scale, higher is good.	3.5, 7 months
Subset effects in those citing prior coQ10 use, stratified by whether benefit had been perceived.		3.5, 7 months
Analysis stratified by presence of symptoms compatible with sleep apnea	For inclusion in sleep apnea stratum during analysis, the following will be qualifying: Diagnosed sleep apnea, nocturia, awaking from sleep gasping or choking (or observed by others gasping or choking during sleep), daytime hypersomnolence, night sweats, or awaking with headache or anxiety. This is exploratory, but each outcome will be stratified by sleep apnea-compatible problems.	3.5, 7 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Beatrice A Golomb, MD, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: War-Related Injuries; Wounds and Injuries; Metabolic Diseases; Occupational Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases; Persian Gulf Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Ubiquinone; Coenzyme Q10
• Other Study ID Numbers: GW190064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No