Gulf War IllnessPhase 3NCT02865460
Coenzyme Q10 Phase III Trial in Gulf War Illness
A Phase 3 study testing Ubiquinol in people with Gulf War Illness and Chronic Fatigue, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Gulf War Illness, Chronic Fatigue, Ubiquinol
- What is being tested?
- Ubiquinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jul 2017to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Veterans who were deployed in 1990 -1991 Gulf War.
- Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
- Veterans who were in good health based on medical history prior to 1990.
- Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.
Who cannot join
- Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:
- severe psychiatric problems
- schizophrenia
- bipolar disorder
- major depression with psychotic or melancholic features
- delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.
Show all 23Show fewer
- Has dementias of any type
- Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).
- Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.
- Medical conditions excluded:
- organ failure
- defined rheumatologic inflammatory disorders
- chronic active infections such as HIV, hepatitis B and C, or transplant
- primary sleep disorders
- Medications that could potentially impact immune function excluded:
- steroids
- immune-suppressives
- nutraceuticals that are formulated to impact mitochondrial function or oxidative stress
- Biologic response modifiers within 3 months of study entry.
- Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
- Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
- Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.
- Common multivitamin preparations will be allowed if taken without change throughout the protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.
Read the detailed description
As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction Exploratory studies using interventions that support cell functioning and prevent or repair stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing physical functioning for Veterans with Gulf War Illness.
This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.
- Conditions
- Gulf War Illness, Chronic Fatigue, Ubiquinol, Coenzyme Q10
- Being tested
- Ubiquinol, Placebo
- Keywords
- Chronic Pain, Cognitive Disorders, Inflammation, Neurologic manifestations, Dementia, Mental Disorders, Ubiquinol/ubiquinone, Pathologic Processes, Nervous System Diseases, Hormones, Hormone Substitutes, and Hormone Antagon, Anti-Inflammatory Agents, Pharmacologic Actions, Therapeutic Uses, Physiological Effects of Drugs, Gulf war illness, Chronic fatigue
- Medical subject headings
- Chronic Pain, Cognitive Dysfunction, Inflammation, Neurologic Manifestations, Dementia, Mental Disorders, Pathologic Processes, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinolDrug
Also called Coenzyme Q10, CoQ10
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
PlaceboDrug
Also called Sugar pill, inactive substance
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinol | Experimental | Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Receives: Drug: Ubiquinol |
| Placebo | Placebo comparator | Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Short Form 36-Item Health Survey Physical Component Summary
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcomes (30)
Multidimensional Fatigue Inventory (MFI)
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Gulf War Illness Health Symptom Checklist
The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28
Brief Pain Inventory
The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Pittsburgh Sleep Quality Index
The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Hamilton Anxiety Scale (HAM-A)
This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety.
Measured: Baseline, Weeks 8, 16, and 24
Hamilton Depression Scale (HAM-D)
This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression.
Measured: Baseline, Weeks 8, 16, and 24
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes.
Measured: Baseline, Weeks 8, 16, and 24
Connors Continuous Performance Test (CPT-3):Omissions T-score
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes.
Measured: Baseline, Weeks 8, 16, and 24
Connors Continuous Performance Test (CPT-3):Commissions T-score
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes.
Measured: Baseline, Weeks 8, 16, and 24
Brief Visual Memory Test (BVMT): Delayed Recall
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance.
Measured: Baseline, Weeks 8, 16, and 24
Brief Visual Memory Test (BVMT): Percent Retained
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance.
Measured: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance.
Measured: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Short Delay
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance.
Measured: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Long Delay Test
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance.
Measured: Baseline, Weeks 8, 16, and 24
Davidson Trauma Scale
Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.
Measured: Baseline, Weeks 8, 16, and 24
FitBit Sleep Measurement - Total Sleep
FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.
Measured: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
FitBit Sleep Measurement - Types of Sleep
FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.
Measured: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Cortisol Levels
Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.
Measured: Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
HPG will measure testosterone. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
HPG will measure progesterone. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
HPG will measure estradiol. Average values fell within the normal range for this type of assay.
Measured: Baseline, Weeks 8, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start24 Jul 2017
- Primary completion7 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nancy G Klimas, BS MD, Principal investigator, Miami VA Healthcare System, Miami, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865460
- Sponsor's protocol ID
- SPLD-04-15F
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2016
- Last updated
- 15 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
- ClinicalTrials.gov ID
- NCT02865460
- Acronym / sponsor ID
- SPLD-04-15F
- Conditions
- Gulf War Illness, Chronic Fatigue, Ubiquinol, Coenzyme Q10
- Keywords
- Chronic Pain, Cognitive Disorders, Inflammation, Neurologic manifestations, Dementia, Mental Disorders, Ubiquinol/ubiquinone, Pathologic Processes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 15 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.
Detailed description
As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction Exploratory studies using interventions that support cell functioning and prevent or repair stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing physical functioning for Veterans with Gulf War Illness.
This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ubiquinol | Experimental | Drug: UbiquinolTake oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking |
| Placebo | Placebo comparator | Drug: PlaceboTake oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female Veterans who were deployed in 1990 -1991 Gulf War.
- Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
- Veterans who were in good health based on medical history prior to 1990.
- Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.
Key exclusion criteria (23 listed)
- Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:
- Medical conditions excluded:
- Medications that could potentially impact immune function excluded:
- Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
- Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
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 |
|---|---|---|
| UbiquinolAlso: Coenzyme Q10, CoQ10Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking | Drug | Ubiquinol |
| PlaceboAlso: Sugar pill, inactive substanceTake oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking | Drug | Placebo |
Primary outcome
Veterans Short Form 36-Item Health Survey Physical Component Summary
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health.
30 secondary outcomes
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Gulf War Illness Health Symptom Checklist
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28
Brief Pain Inventory
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Pittsburgh Sleep Quality Index
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Hamilton Anxiety Scale (HAM-A)
Time frame: Baseline, Weeks 8, 16, and 24
Hamilton Depression Scale (HAM-D)
Time frame: Baseline, Weeks 8, 16, and 24
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
Time frame: Baseline, Weeks 8, 16, and 24
Connors Continuous Performance Test (CPT-3):Omissions T-score
Time frame: Baseline, Weeks 8, 16, and 24
Connors Continuous Performance Test (CPT-3):Commissions T-score
Time frame: Baseline, Weeks 8, 16, and 24
Brief Visual Memory Test (BVMT): Delayed Recall
Time frame: Baseline, Weeks 8, 16, and 24
Brief Visual Memory Test (BVMT): Percent Retained
Time frame: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
Time frame: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Short Delay
Time frame: Baseline, Weeks 8, 16, and 24
California Verbal Learning Test (CVLT-II): Long Delay Test
Time frame: Baseline, Weeks 8, 16, and 24
Davidson Trauma Scale
Time frame: Baseline, Weeks 8, 16, and 24
FitBit Sleep Measurement - Total Sleep
Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
FitBit Sleep Measurement - Types of Sleep
Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Cortisol Levels
Time frame: Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
Time frame: Baseline, Weeks 8, 16, and 24
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
Time frame: Baseline, Weeks 8, 16, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nancy G Klimas, BS MD principal investigator
Miami VA Healthcare System, Miami, FL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ubiquinol in people with Gulf War Illness and Chronic Fatigue, run by VA Office of Research and Development at 4 sites 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 4 inclusion and 23 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Veterans Short Form 36-Item Health Survey Physical Component Summary (time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.