CompletedNot Applicable

Mitochondrial Cocktail for Gulf War Illness

United States15 participantsStarted 2021-04-09

Plain-language summary

The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).

Who can participate

Age range48 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet symptom criteria for Gulf War illness with BOTH the Centers for Disease Control and Prevention (CDC) Criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and Kansas Criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, GI and respiratory). Exclusion Criteria: * Have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for Gulf War illness. * Participating in a concurrent treatment trial. * Unwilling or unable to comply with the treatment protocol * Failed run-in; do not take at least 80% of run-in medications

What they're measuring

Mean change in single item General Self-Rated Health Visual Analog Scale from baseline

Timeframe: 0, 3, 6 months (double-blind phase)

Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises

Timeframe: 6 months (double-blind phase)

Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo

Timeframe: 0, 3, 6 months (double-blind phase)

Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo

Timeframe: 6 months (double-blind phase)

Trial details

NCT IDNCT02804828

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-03

View on ClinicalTrials.gov More Gulf War Syndrome trials

Who can participate

Age range48 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean change in single item General Self-Rated Health Visual Analog Scale from baseline

Timeframe: 0, 3, 6 months (double-blind phase)

Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises

Timeframe: 6 months (double-blind phase)

Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo

Timeframe: 0, 3, 6 months (double-blind phase)

Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo

Timeframe: 6 months (double-blind phase)