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Mitochondrial Cocktail for Gulf War Illness

Primary Purpose

Gulf War Syndrome, Persian Gulf Syndrome, Mitochondrial Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized mitochondrial cocktail
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gulf War Syndrome

Eligibility Criteria

48 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2015
Last Updated
April 4, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02804828
Brief Title
Mitochondrial Cocktail for Gulf War Illness
Official Title
Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gulf War Syndrome, Persian Gulf Syndrome, Mitochondrial Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Design study is followed by Crossover to open label treatment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Sham Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Individualized mitochondrial cocktail
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
6 months for the double-blind phase
Primary Outcome Measure Information:
Title
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
Time Frame
0, 3, 6 months (double-blind phase)
Title
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
Time Frame
6 months (double-blind phase)
Title
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)
Title
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo
Time Frame
6 months (double-blind phase)
Secondary Outcome Measure Information:
Title
Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)
Description
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).
Time Frame
6, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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Mitochondrial Cocktail for Gulf War Illness

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