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Mitochondrial Cocktail for Gulf War Illness

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ClinicalTrials.gov Identifier: NCT02804828
Recruitment Status : Not yet recruiting
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
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 plus individualized correction of citric acid cycle (CAC) intermediates and amino acid (AA) abnormalities as part of a mitochondrial/oxidative stress treatment approach 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: Arctic cod liver oil capsules Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Primary Completion Date : September 2018


Arm Intervention/treatment
Active Comparator: Arm 1 Dietary Supplement: Individualized mitochondrial cocktail
Dietary Supplement: Arctic cod liver oil capsules
Sham Comparator: Arm 2 Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Change from baseline of predictive biological markers of Gulf War illness (including α-ketoglutarate, fumarate, malate, citrate, and isocitrate) in blood [ Time Frame: 0, 6, 12 months ]


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Ages Eligible for Study:   43 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.

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


Contacts
Contact: Janis B. Ritchie, BSN 858-558-4950 jbritchie@ucsd.edu

Sponsors and Collaborators
University of California, San Diego

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

Additional relevant MeSH terms:
Persian Gulf Syndrome
Syndrome
Mitochondrial Diseases
Disease
Pathologic Processes
Occupational Diseases
Metabolic Diseases
Cod Liver Oil
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs