Q10 for Gulf War Veterans (GULF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Beatrice Golomb, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01011348
First received: November 10, 2009
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Gulf War Illness
Dietary Supplement: Coenzyme Q10
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Q10 for Gulf War Veterans

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: July 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo vs Q10 100mg vs Q10 300mg Dietary Supplement: Coenzyme Q10
100mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Coenzyme Q10
300mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Placebo
Three month period
Other Name: PharmaNord matched identical softgel placebo
Q10 100mg vs Placebo vs Q10 300mg Dietary Supplement: Coenzyme Q10
100mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Coenzyme Q10
300mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Placebo
Three month period
Other Name: PharmaNord matched identical softgel placebo
Placebo vs. Q10 300mg vs. Q10 100mg Dietary Supplement: Coenzyme Q10
100mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Coenzyme Q10
300mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Placebo
Three month period
Other Name: PharmaNord matched identical softgel placebo
Q10 300mg vs. Placebo vs. Q10 100mg Dietary Supplement: Coenzyme Q10
100mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Coenzyme Q10
300mg/day for three months
Other Name: PharmaNord Myoquinione softgel caplets
Dietary Supplement: Placebo
Three month period
Other Name: PharmaNord matched identical softgel placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011348

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Beatrice A Golomb, M.D., Ph.D. University of California, San Diego
  More Information

Additional Information:
No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beatrice Golomb, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01011348     History of Changes
Other Study ID Numbers: W81WH-07-1-0667
Study First Received: November 10, 2009
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Gulf War Illness
Coenzyme Q10
Quality of Life
Fatigue
oxidative stress

Additional relevant MeSH terms:
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on August 18, 2014