Mitochondrial Cocktail for Gulf War Illness

Not Applicable

Completed

• Conditions: Gulf War Syndrome; Mitochondrial Disorders; Persian Gulf Syndrome
• Interventions: Dietary Supplement: Individualized mitochondrial cocktail; Dietary Supplement: Placebo

• Registration Number: NCT02804828
• Lead Sponsor: 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).

Detailed Description

See below.

Study Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2021-04-09
• Status Verified: 2023-04
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-03
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Individualized mitochondrial cocktail	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo	0, 3, 6 months (double-blind phase)
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline	0, 3, 6 months (double-blind phase)
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises	6 months (double-blind phase)
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo	6 months (double-blind phase)

Secondary Outcome Measures

Name	Time	Method
Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)	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).

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States