Gulf War IllnessGULFNCT01011348
Q10 for Gulf War Veterans
A study testing Coenzyme Q10 in people with Gulf War Illness, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Gulf War Illness
- Being tested
- Coenzyme Q10, Placebo
- Keywords
- Gulf War Illness, Coenzyme Q10, Quality of Life, Fatigue, oxidative stress
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Also called PharmaNord Myoquinione softgel caplets
100mg/day for three months
Coenzyme Q10Dietary supplement
Also called PharmaNord Myoquinione softgel caplets
300mg/day for three months
PlaceboDietary supplement
Also called PharmaNord matched identical softgel placebo
Three month period
| Study group | Role | What they receive |
|---|---|---|
| Placebo vs Q10 100mg vs Q10 300mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 100mg vs Placebo vs Q10 300mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Placebo vs. Q10 300mg vs. Q10 100mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
| Q10 300mg vs. Placebo vs. Q10 100mg | Other | Not described Receives: Dietary Supplement: Coenzyme Q10; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coenzyme Q10 will improve overall subjective quality of life in ill Gulf War Veterans, using a single item General Self-Rated Health measure.
Measured: Assessed every three months for one year
Secondary outcomes (4)
Coenzyme Q10 will improve specific symptoms that dominate definitions of illness in GWV including fatigue, pain, and muscle strength.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessed every three months over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Beatrice A Golomb, M.D., Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011348
- Sponsor's protocol ID
- W81WH-07-1-0667
- Acronym
- GULF
- Status last verified
- Feb 2020
- First submitted
- 10 Nov 2009
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Erickson LC, Ritchie JB, Javors JM, Golomb BA. Recruiting a special sample with sparse resources: lessons from a study of Gulf War veterans. Clin Trials. 2013;10(3):473-82. doi: 10.1177/1740774512470040. Epub 2013 Jan 16.
PubMed 23325028
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q10 for Gulf War Veterans
- ClinicalTrials.gov ID
- NCT01011348
- Acronym / sponsor ID
- GULF / W81WH-07-1-0667
- Conditions
- Gulf War Illness
- Keywords
- Gulf War Illness, Coenzyme Q10, Quality of Life, Fatigue, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo vs Q10 100mg vs Q10 300mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 100mg vs Placebo vs Q10 300mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Placebo vs. Q10 300mg vs. Q10 100mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
| Q10 300mg vs. Placebo vs. Q10 100mg | Other | Dietary Supplement: Coenzyme Q10, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: PharmaNord Myoquinione softgel caplets100mg/day for three months | Dietary supplement | Placebo vs Q10 100mg vs Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs Placebo vs Q10 300mg, Q10 300mg vs. Placebo vs. Q10 100mg |
| Coenzyme Q10Also: PharmaNord Myoquinione softgel caplets300mg/day for three months | Dietary supplement | Placebo vs Q10 100mg vs Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs Placebo vs Q10 300mg, Q10 300mg vs. Placebo vs. Q10 100mg |
| PlaceboAlso: PharmaNord matched identical softgel placeboThree month period | Dietary supplement | Placebo vs Q10 100mg vs Q10 300mg, Placebo vs. Q10 300mg vs. Q10 100mg, Q10 100mg vs Placebo vs Q10 300mg, Q10 300mg vs. Placebo vs. Q10 100mg |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 23325028Erickson LC, Ritchie JB, Javors JM, Golomb BA. Recruiting a special sample with sparse resources: lessons from a study of Gulf War veterans. Clin Trials. 2013;10(3):473-82. doi: 10.1177/1740774512470040. Epub 2013 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice A Golomb, M.D., Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Gulf War Illness, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.