Coenzyme Q10 for Gulf War Illness: A Replication Study

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06515184
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • PharmaNord Bio-Quinone Active CoQ10 Gold 100mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 13, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CoQ10 Arm 1
    PharmaNord Ubiquinone 100mg/1x day
  • Active Comparator: CoQ10 Arm 2
    PharmaNord Ubiquinone 100mg/3x day
  • Placebo Comparator: Placebo Arm
    Placebo (made by PharmaNord, matches active treatment)

Primary Outcome 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. [ Time Frame: 3.5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093
Janis B. Ritchie, BSN
[email protected]
858-558-4950
Beatrice A. Golomb, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UC San Diego· La Jolla, CA

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