Coenzyme Q10 for Gulf War Illness: A Replication Study

University of California San Diego

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: PharmaNord Placebo; Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06515184

GW190064

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 3 patient groups, including a placebo group

CoQ10 Arm 1

Active Comparator group

Description:

PharmaNord Ubiquinone 100mg/1x day

Treatment:

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

CoQ10 Arm 2

Active Comparator group

Description:

PharmaNord Ubiquinone 100mg/3x day

Treatment:

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Placebo Arm

Placebo Comparator group

Description:

Placebo (made by PharmaNord, matches active treatment)

Treatment:

Drug: PharmaNord Placebo