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Recruiting NCT06515184

Coenzyme Q10 for Gulf War Illness: A Replication Study

Phase III Interventional Gulf War Syndrome Persian Gulf Syndrome Mitochondrial Disorder, Respiratory Chain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg, PharmaNord Placebo, PharmaNord Bio-Quinone Active CoQ10 Gold 100mg.
Who it may be relevant to
Registry conditions: Gulf War Syndrome, Persian Gulf Syndrome, Mitochondrial Disorder, Respiratory Chain. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score. [Time frame: 3.5 months]
  • Mean change in single-item General Self-Rated Health (GSRH). [Time frame: 3.5 months]
  • Individual GWI Symptoms [Time frame: 3.5, 7 months]
  • Relation of change in time to do five chair rises to change in blood level of coenzyme Q10 [Time frame: 3.5, 7 months]
  • Effect of CoQ10 in the majority male subset on symptoms. [Time frame: 3.5, 7 months]
  • Effect of CoQ10 in the majority male subset on timed chair rises. [Time frame: 3.5, 7 months]
  • Effect of CoQ10 in the majority male subset on GSRH. [Time frame: 3.5, 7 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UC San Diego — La Jolla

Identifiers

NCT: NCT06515184 · GW190064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗