Q10 for Gulf War Veterans (GULF)

February 5, 2020 updated by: University of California, San Diego

Goal: The investigators propose to test whether giving the supplement coenzyme Q10 (Q10) improves symptoms and subjective health in Gulf War veterans (GWV) with chronic, multi-symptom health problems.

Rationale: Direct empirical evidence, in groups that are not GWV, has supported benefit of Q10 to many of the symptoms that GWV are at heightened risk of experiencing - such as fatigue, muscle pain, and cognition, which are syndrome-defining conditions. In addition, Q10 has also been reported to benefit other symptoms arising at increased rates in GWV, including headaches, sleep disturbances, and breathing problems. This provides a strong rationale for testing whether Q10 will have similar benefit to these symptoms in GWV.

Method: 46 GWV with chronic health problems will participate.The design is a randomized, double-blind, placebo-controlled crossover study. Each subject will be "crossed over" between Q10 and an identical placebo, receiving each agent twice, for 3.5 month periods. In one of the Q10 phases, a lower dose of Q10 will be used - 100mg three times a day; while in one a higher dose will be used - 300mg three times a day. Neither subjects nor investigators will know which substance each subject is receiving in which phase. Subjects will be randomly assigned to one of four crossover orders.

Assessments: Assessments will include subjective quality of life; symptoms that are "syndrome defining" for Gulf War illness (like fatigue and muscle problems); and other symptoms and conditions reported to occur more commonly in GWV (like sleep problems). Analyses will show whether Q10 led to improvements when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses; and whether people with certain symptoms or characteristics get more benefit than people with other symptoms or characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Goal: To determine, via a double-blind placebo-controlled crossover study, whether coenzyme Q10 (Q10) administration reduces symptoms and improve subjective health in Gulf War veterans (GWV).

Rationale: In a number of settings, studies have reported benefits of Q10 to fatigue, muscle pain and cognition, "syndrome" defining symptoms in GWV. It has also been reported to improve a range of other symptoms and conditions that arise at increased rates in GWV. Additionally Q10 defends against mechanisms that may play a role in health problems in GWV. For these reasons, a study evaluating benefits by Q10 to symptoms and quality of life in symptomatic GWV is merited.

Subjects: 46 GWV meeting Center for Disease Control (CDC) and Kansas criteria for "Gulf War illness." Design: Randomized, placebo-controlled, double-blind crossover study. Intervention: Coenzyme Q10 at 100mg three times a day (tid) or 300mg tid or matching placebo for 3.5 ± 0.5 month periods.

Primary Outcome: Subjective health; syndrome defining symptoms (fatigue, muscle pain, muscle strength; and cognition).

Secondary Outcomes: A variety of secondary outcomes will be assessed including other symptoms reported to be elevated in GWV; markers of oxidative stress; and dose-response.

Analyses: Nonparametric and secondarily parametric analyses will compare effects of Q10 vs placebo; and of higher dose vs lower dose Q10 on primary and secondary endpoints. Possible effect modification (differential benefit) based on factors such as oxidative state and Q10 serum concentration will be explored through regression analysis.

Study Type

Interventional

Enrollment (Actual)

58

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
        • University of California, 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Deployed to the Middle East for any period between August 1990 and July 1991.
  • Adherence to CDC criteria for Gulf War illness: Chronic symptoms, for at least six months, first arising after Gulf deployment, in at least two of the three areas of fatigue, musculoskeletal, and mood/cognition.
  • Adherence to Kansas criteria for Gulf War illness. To aid specificity, these criteria are more involved than CDC criteria Veterans are asked about symptoms in several general categories (e.g., respiratory, gastrointestinal, neuropsychological, sleep disturbances, pain), as well as symptoms (e.g., fatigue, headache) for which no single category is apparent. Gulf War illness criteria symptoms must have persisted or recurred in the year prior to interview and first have been a problem for respondents in 1990 or later. Full criteria are as delineated in Steele 2000.
  • Willing to agree to defer initiating other over the counter medications till after completion of study participation.
  • Willing to defer participation in other clinical trials till after completion of study participation.
  • If female of childbearing potential, willing to be on two forms of birth control during study participation.

Exclusion Criteria:

  • Any factor that might compromise participation for the full duration of the study.
  • Known active cancer (except nonmelanoma skin cancer), neurodegenerative disease, or HIV.
  • Active medical problems distinct from Gulf War symptomatology that confer a significant probability of hospitalization, medication change, or change in clinical state during the course of participation.
  • Use of coumadin.
  • Use of Q10-containing products, including lotions, toothpastes, or supplements in the prior two months.
  • Current use of drugs known to be mitochondrial toxins: amiodarone, protease inhibitors, fluoroquinoline ("floxin") antibiotics.
  • Nursing or pregnant women.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo vs. Q10 300mg vs. Q10 100mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 300mg vs. Placebo vs. Q10 100mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Placebo vs Q10 100mg vs Q10 300mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo
Other: Q10 100mg vs Placebo vs Q10 300mg
Dietary supplement: Coenzyme Q10
100mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Coenzyme Q10
300mg/day for three months
Other Names:
  • PharmaNord Myoquinione softgel caplets
Dietary supplement: Placebo
Three month period
Other Names:
  • PharmaNord matched identical softgel placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coenzyme Q10 will improve overall subjective quality of life in ill Gulf War Veterans, using a single item General Self-Rated Health measure.
Time Frame: Assessed every three months for one year
Assessed every three months for one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Coenzyme Q10 will improve specific symptoms that dominate definitions of illness in GWV including fatigue, pain, and muscle strength.
Time Frame: Assessed every three months over one year
Assessed every three months over one year
Coenzyme Q10 will subjectively improve other symptoms reported to arise at elevated rates in GWV defined by responses on a symptom survey (e.g. headache, shortness of breath, sleep problems, gastrointestinal problems).
Time Frame: Assessed every three months over one year
Assessed every three months over one year
Effect modification: The magnitude of Coenzyme Q10 (Q10) benefit may be influenced by baseline oxidative state, change in oxidation with Q10, and serum Q10 level; or by which symptoms a veteran has.
Time Frame: Assessed every three months over one year
Assessed every three months over one year
Assess whether higher dose Q10 provides greater benefit; or does so selectively in individuals with more unfavorable baseline oxidation state; or individuals who require a higher dose to achieve the same change in Q10, e.g. due to impaired assimilation.
Time Frame: Assessed every three months over one year
Assessed every three months over one year

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Collaborators

United States Department of Defense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81WH-07-1-0667

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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