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OpenTrials
Completed

NCT Number: NCT02804828

Mitochondrial Cocktail for Gulf War Illness

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).

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Key information

Conditions

Gulf War Syndrome Metabolic Diseases Mitochondrial Diseases Mitochondrial Disorders Nutritional and Metabolic Diseases Occupational Diseases Persian Gulf Syndrome War-Related Injuries Wounds and Injuries

Age range

48 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

See below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized mitochondrial cocktail

Dietary Supplement

Nutrient cocktail comprising: thiamine, nicotinamide, pantothenic acid, riboflavin, L-carnitine, alpha lipoic acid, CoQ10, vitamin C, vitamin E, and omega 3 fatty acids (Cod Liver Oil).

Placebo

Dietary Supplement

6 months for the double-blind phase

Primary outcomes

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

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

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

    Time frame: 6 months (double-blind phase)

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

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

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

    Time frame: 6 months (double-blind phase)

Secondary outcomes

  1. Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)

    Time frame: 6, 9, 12 months

    Secondary measures will incorporate assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) at primary endpoint time point. We will assess at additional time points (9, 12 month) and will assess effects stratified by sex; by dominant ethnicity; and by use of medications that can affect levels or disposition of supplement components (e.g. statin use).

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2016
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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