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Mitochondrial Cocktail for Gulf War Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02804828
Recruitment Status : Not yet recruiting
First Posted : June 17, 2016
Last Update Posted : February 13, 2020
Information provided by (Responsible Party):
Beatrice Golomb, University of California, San Diego

Brief 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).

Condition or disease Intervention/treatment Phase
Gulf War Syndrome Persian Gulf Syndrome Mitochondrial Disorders Dietary Supplement: Individualized mitochondrial cocktail Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Active Comparator: Arm 1 Dietary Supplement: Individualized mitochondrial cocktail
Nutrient cocktail comprising: B-vitamins, carnitine, alpha lipoic acid, coq10, vitamin C, vitamin E, and omega 3 fatty acids. Depending on the participant, citrulline/arginine or methionine.

Sham Comparator: Arm 2 Dietary Supplement: Placebo
6 months for the double-blind phase

Primary Outcome Measures :
  1. Mean change in single item General Self-Rated Health Visual Analog Scale from baseline to 6 months [ Time Frame: 0, 3, 6 months (double-blind phase) ]
  2. Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises from 0 to 6 months [ 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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   46 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02804828

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Contact: Janis B. Ritchie, BSN 858-558-4950

Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Beatrice Golomb, Professor of Medicine, University of California, San Diego Identifier: NCT02804828    
Other Study ID Numbers: GW140146
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitochondrial Diseases
Persian Gulf Syndrome
Pathologic Processes
Occupational Diseases
Metabolic Diseases