Coenzyme Q10 for Gulf War Illness: A Replication Study

NCT06515184 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GW190064
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Disorder, Respiratory Chain; Gulf War Syndrome; Persian Gulf Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.

  3.5 months

• Mean change in single-item General Self-Rated Health (GSRH).

  3.5 months

• Individual GWI Symptoms

  3.5, 7 months

• Relation of change in time to do five chair rises to change in blood level of coenzyme Q10

  3.5, 7 months

• Effect of CoQ10 in the majority male subset on symptoms.

  3.5, 7 months

Other Outcomes (17)

• The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm 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.

  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.

  3.5, 7 months

Study Arms (3)

CoQ10 Arm 1

ACTIVE COMPARATOR

PharmaNord Ubiquinone 100mg/1x day

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

CoQ10 Arm 2

ACTIVE COMPARATOR

PharmaNord Ubiquinone 100mg/3x day

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Placebo Arm

PLACEBO COMPARATOR

Placebo (made by PharmaNord, matches active treatment)

Drug: PharmaNord Placebo

Interventions

PharmaNord Bio-Quinone Active CoQ10 Gold 100mg DRUG

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.

CoQ10 Arm 1

PharmaNord Placebo DRUG

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.

Placebo Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• United States Department of Defense: collaborator

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Beatrice A Golomb, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janis B Ritchie, BSN

CONTACT

858-558-4950; jbritchie@ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Parallel Design (primary) is followed by active treatment phase (still blind to dose).

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 23, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)