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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804828
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : September 7, 2022
Sponsor:
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

Detailed Description:
See below.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Design study is followed by Crossover to open label treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Active Comparator: Arm 1 Dietary Supplement: Individualized mitochondrial cocktail
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).

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 [ 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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02804828


Locations
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United States, California
UC San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
  Study Documents (Full-Text)

Documents provided by Beatrice Golomb, University of California, San Diego:
Informed Consent Form  [PDF] March 17, 2022

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Responsible Party: Beatrice Golomb, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02804828    
Other Study ID Numbers: GW140146
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022

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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
Syndrome
Persian Gulf Syndrome
Disease
Pathologic Processes
Occupational Diseases
Metabolic Diseases