Mitochondrial Cocktail for Gulf War Illness

April 4, 2023 updated by: Beatrice Golomb, University of California, San Diego

Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See below.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in single item General Self-Rated Health Visual Analog Scale from baseline
Time Frame: 0, 3, 6 months (double-blind phase)
0, 3, 6 months (double-blind phase)
Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises
Time Frame: 6 months (double-blind phase)
6 months (double-blind phase)
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)
0, 3, 6 months (double-blind phase)
Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo
Time Frame: 6 months (double-blind phase)
6 months (double-blind phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6, 9, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

April 3, 2023

Study Completion (Actual)

April 3, 2023

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW140146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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