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CompletedNCT02865460Updated Feb 15, 2023Results posted

Coenzyme Q10 Phase III Trial in Gulf War Illness

A Phase 3 interventional study of Ubiquinol and Placebo in Gulf War Illness, Chronic Fatigue and Ubiquinol, sponsored by VA Office of Research and Development. Completed at 4 sites in United States. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by VA Office of Research and Development · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Gulf War Illness
  • Chronic Fatigue
  • Ubiquinol
  • Coenzyme Q10

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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
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 100 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
    • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Ubiquinol

    Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

    Drug: Ubiquinol

  • Placebo comparator
    Placebo

    Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking

    Drug: Placebo

Interventions

  • DrugUbiquinol

    Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

    Also known as: Coenzyme Q10, CoQ10

  • DrugPlacebo

    Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

    Also known as: Sugar pill, inactive substance

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary outcomes

  1. 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.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

  2. 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.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28

  3. Brief Pain Inventory

    The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

  4. 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.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

  5. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  6. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  7. 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.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

  8. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  9. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  10. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  11. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  12. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  13. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  14. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  15. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  16. Davidson Trauma Scale

    Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.

    Time frame: Baseline, Weeks 8, 16, and 24

  17. 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.

    Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks

  18. 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.

    Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks

  19. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  20. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  21. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  22. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  23. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  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.

    Time frame: Baseline, Weeks 8, 16, and 24

  25. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  26. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  27. Response to Therapy on Cortisol Levels

    Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.

    Time frame: Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.

  28. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  29. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

  30. 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.

    Time frame: Baseline, Weeks 8, 16, and 24

07

Results

Posted Feb 15, 2023
Limitations and caveats
Study recruitment closed on 4/1/2020, coinciding with the onset of the COVID-19 pandemic. Participants could not complete their in-person visits due to the closure of VA research services and VA outpatient labs.

Participant flow

Participant flow — Overall Study
MilestoneUbiquinolPlacebo
Started5149
Completed4143
Not completed106
Withdrew: Adverse event10
Withdrew: Withdrawal by subject11
Withdrew: Lost to follow-up74
Withdrew: Ubiquinol group -not deployed to gulf; placebo group- ill with covid11

Outcome measures

PrimaryVeterans 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.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Reported as:
Mean · units on a scale
Veterans Short Form 36-Item Health Survey Physical Component Summary
units on a scaleUbiquinolPlacebo
Change Baseline to 4 Weeks1.6 ± 11.1-1.1 ± 10.1
Change Baseline to 8 Weeks1.4 ± 12.71.1 ± 10.3
Change Baseline to 12 Weeks1.5 ± 15.9-1.8 ± 13.1
Change Baseline to 16 Weeks2.1 ± 14.51.8 ± 12.4
Change Baseline to 20 Weeks1.6 ± 14.70.7 ± 14.3
Change Baseline to 24 Weeks0.7 ± 12.50.3 ± 12.7
SecondaryMultidimensional 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.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Reported as:
Mean · score on a scale
Multidimensional Fatigue Inventory (MFI)
score on a scaleUbiquinolPlacebo
Change Baseline to 4 Weeks-0.6 ± 8.30.2 ± 10
Change Baseline to 8 Weeks-1.8 ± 9.90.5 ± 8
Change Baseline to 12 Weeks-1.4 ± 103.6 ± 8.4
Change Baseline to 16 Weeks-3.2 ± 9.50.3 ± 8.1
Change Baseline to 20 Weeks-0.5 ± 7.52.5 ± 9.0
Change Baseline to 24 Weeks-2.3 ± 9.70.8 ± 8.7
SecondaryGulf 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.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28
Reported as:
Mean · units on a scale
Gulf War Illness Health Symptom Checklist
units on a scaleUbiquinolPlacebo
Change from baseline to 4 weeks-3.7 ± 8.8-2.0 ± 6.3
Change from baseline to 8 weeks-3.7 ± 7.5-2.6 ± 9.4
Change from baseline to 12 weeks-5.8 ± 10.8-2.7 ± 9.4
Change from baseline to 16 weeks-4.6 ± 9.5-1.6 ± 6.1
Change from baseline to 20 weeks-6.1 ± 11.9-3.7 ± 10.3
Change from baseline to 24 weeks-3.8 ± 8.6-3.1 ± 8.0
Change from baseline to 28 weeks-8.7 ± 11.5-9.4 ± 13.3
SecondaryBrief Pain Inventory

The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Reported as:
Mean · units on a scale
Brief Pain Inventory
units on a scaleUbiquinolPlacebo
Change from baseline to 4 weeks0 ± 1.10 ± 1.3
Change from baseline to 8 weeks-0.1 ± 1.60.3 ± 1.6
Change from baseline to 12 weeks0.3 ± 1.70.3 ± 1.6
Change from baseline to 16 weeks-0.1 ± 1.80.1 ± 1.4
Change from baseline to 20 weeks0.2 ± 1.60.6 ± 1.8
Change from baseline to 24 weeks-0.3 ± 1.4-0.3 ± 1.5
SecondaryPittsburgh 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.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Reported as:
Mean · units on a scale
Pittsburgh Sleep Quality Index
units on a scaleUbiquinolPlacebo
Change from baseline to 4 weeks-1.0 ± 2.80.0 ± 3.1
Change from baseline to 8 weeks-1.2 ± 2.9-0.4 ± 2.8
Change from baseline to 12 weeks-1.7 ± 3.40.1 ± 3.6
Change from baseline to 16 weeks-1.6 ± 3.0-1.0 ± 3.0
Change from baseline to 20 weeks-0.3 ± 3.70.3 ± 3.7
Change from baseline to 24 weeks-1.4 ± 3.5-0.4 ± 3.5
SecondaryHamilton 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · units on a scale
Hamilton Anxiety Scale (HAM-A)
units on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks-0.9 ± 9.31.7 ± 10.3
Change from baseline to 16 weeks-0.7 ± 8.3-1.7 ± 8.3
Change from baseline to 24 weeks-1.5 ± 9.00.1 ± 10.3
SecondaryHamilton 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · units on a scale
Hamilton Depression Scale (HAM-D)
units on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks-2.4 ± 6.1-1.3 ± 4.9
Change from baseline to 16 weeks-2.8 ± 5.8-3.6 ± 4.5
Change from baseline to 24 weeks-2.5 ± 7.0-2.8 ± 5.8
SecondaryVeterans 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.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Reported as:
Mean · score on a scale
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
score on a scaleUbiquinolPlacebo
Change from baseline to 4 weeks4.5 ± 12.60.4 ± 12.8
Change from baseline to 8 weeks4.2 ± 14.93.6 ± 14.8
Change from baseline to 12 weeks4.0 ± 19.52.8 ± 10.6
Change from baseline to 16 weeks3.8 ± 15.54.9 ± 13.9
Change from baseline to 20 weeks-3.7 ± 17.43.1 ± 15.8
Change from baseline to 24 weeks2.6 ± 16.31.1 ± 13.5
SecondaryConnors 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
score on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks10.7 ± 43.1-1.6 ± 34.3
Change from baseline to 16 weeks17.2 ± 46.9-3.0 ± 49
Change from baseline to 24 weeks24.0 ± 46.912.8 ± 45.4
SecondaryConnors 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · T-score
Connors Continuous Performance Test (CPT-3):Omissions T-score
T-scoreUbiquinolPlacebo
Change from baseline to 8 weeks-2.0 ± 7.6-1.2 ± 5.2
Change from baseline to 16 weeks0.2 ± 9.1-1.6 ± 8.5
Change from baseline to 24 weeks-0.4 ± 9.1-1.6 ± 7.8
SecondaryConnors 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · T-score
Connors Continuous Performance Test (CPT-3):Commissions T-score
T-scoreUbiquinolPlacebo
Change from baseline to 8 weeks-3.2 ± 8.0-2.0 ± 5.3
Change from baseline to 16 weeks-3.2 ± 8.6-3.0 ± 6.7
Change from baseline to 24 weeks-3.5 ± 8.8-4.5 ± 7.2
SecondaryBrief 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
Brief Visual Memory Test (BVMT): Delayed Recall
score on a scaleUbiquinolPlacebo
Change from baseline to8 weeks0.3 ± 2.30.3 ± 2.4
Change from baseline to 16 weeks0.3 ± 2.80.9 ± 2.0
Change from baseline to 24 weeks0.4 ± 2.70.4 ± 2.2
SecondaryBrief 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
Brief Visual Memory Test (BVMT): Percent Retained
score on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks-4.1 ± 42.913.7 ± 43
Change from baseline to 16 weeks-5.6 ± 24.61.1 ± 24.7
Change from baseline to 24 weeks-0.4 ± 52.30.4 ± 39.4
SecondaryCalifornia 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
score on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks0.4 ± 7.00.9 ± 9.8
Change from baseline to 16 weeks4.0 ± 8.46.7 ± 7.5
Change from baseline to 24 weeks5.8 ± 8.86.9 ± 10.0
SecondaryCalifornia 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · units on a scale
California Verbal Learning Test (CVLT-II): Short Delay
units on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks0.2 ± 3.00.5 ± 2.4
Change from baseline to 16 weeks1.1 ± 2.51.5 ± 1.9
Change from baseline to 24 weeks1.1 ± 2.61.5 ± 2.8
SecondaryCalifornia 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
California Verbal Learning Test (CVLT-II): Long Delay Test
score on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks-0.4 ± 3.70.6 ± 2.7
Change from baseline to 16 weeks0.3 ± 3.61.6 ± 2.8
Change from baseline to 24 weeks0.9 ± 2.91.4 ± 2.7
SecondaryDavidson Trauma Scale

Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · score on a scale
Davidson Trauma Scale
score on a scaleUbiquinolPlacebo
Change from baseline to 8 weeks-7.6 ± 24.6-6.7 ± 23.4
Change from baseline to 16 weeks-5.4 ± 24.0-12.1 ± 26.5
Change from baseline to 24 weeks-13.3 ± 18.9-9.4 ± 21.8
SecondaryFitBit 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.

Time frame:
Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Reported as:
Mean · minutes
FitBit Sleep Measurement - Total Sleep
minutesUbiquinolPlacebo
Average Total Sleep, Baseline to Week 8344.14 ± 54.6343.4 ± 59.8
Average Total Sleep, Week 8 to Week 16346.31 ± 60.85348.15 ± 57.57
Average Total Sleep, Week 16 to Week 24350.98 ± 58.28334.22 ± 70.86
SecondaryFitBit 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.

Time frame:
Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Reported as:
Mean · average percentage of total time in bed
FitBit Sleep Measurement - Types of Sleep
average percentage of total time in bedUbiquinolPlacebo
Asleep, Baseline to Week 889.06 ± 2.6188.57 ± 1.4
Asleep, Week 8 to Week 1689.1 ± 2.688.5 ± 1.36
Asleep, Week 16 to Week 2488.81 ± 3.4888.85 ± 2.06
Awake, Baseline to Week 810.68 ± 2.7111.34 ± 1.37
Awake, Week 8 to Week 1610.64 ± 4.2811.43 ± 1.92
Awake, Week 16 to Week 2410.92 ± 3.2811.09 ± 2.06
Light Sleep, Baseline to Week 865.37 ± 6.2364.68 ± 7.21
Light Sleep, Week 8 to Week 1667.31 ± 6.4365.89 ± 7.1
Light Sleep, Week 16 to Week 2464.49 ± 6.0465.28 ± 7.98
Deep Sleep, Baseline to Week 815.29 ± 3.6214.7 ± 5.97
Deep Sleep, Week 8 to Week 1614.04 ± 3.9713.82 ± 5.48
Deep Sleep, Week 16 to Week 2415.78 ± 3.5715.23 ± 5.86
REM Sleep, Baseline to Week 819.33 ± 3.866.41 ± 1.31
REM Sleep, Week 8 to Week 1618.65 ± 4.3820.21 ± 3.43
REM Sleep, Week 16 to Week 2419.74 ± 3.9818.75 ± 4.59
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · 1000 cells per microliter
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
1000 cells per microliterUbiquinolPlacebo
WBC, Change from baseline to 8 weeks0.41 ± 2.630.34 ± 1.27
WBC, Change from baseline to 16 weeks0.22 ± 2.540.14 ± 1.27
WBC, Change from baseline to 24 weeks0.22 ± 2.810.44 ± 1.44
Platelets, Change from baseline to 8 weeks-0.94 ± 74.64-2.00 ± 26.20
Platelets, Change from baseline to 16 weeks-5.88 ± 79.943.74 ± 31.36
Platelets, Change from baseline to 24 weeks-6.00 ± 78.0714.48 ± 48.81
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · 1000000 cells per microliter
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
1000000 cells per microliterUbiquinolPlacebo
RBC, Change from baseline to 8 weeks0.10 ± 0.640.01 ± 0.27
RBC, Change from baseline to 16 weeks0.12 ± 0.70-0.03 ± 0.33
RBC, Change from baseline to 24 weeks0.08 ± 0.69-0.02 ± 0.32
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · percentage of white blood cells
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
percentage of white blood cellsUbiquinolPlacebo
Neutrophils, Change from baseline to 8 weeks2.08 ± 15.111.13 ± 9.25
Neutrophils, Change from baseline to 16 weeks0.26 ± 13.970.74 ± 9.36
Neutrophils, Change from baseline to 24 weeks3.33 ± 14.812.04 ± 10.95
Lymphocytes, Change from baseline to 8 weeks-1.64 ± 12.29-0.39 ± 7.83
Lymphocytes, Change from baseline to 16 weeks-0.18 ± 12.730.10 ± 7.66
Lymphocytes, Change from baseline to 24 weeks-3.01 ± 13.22-1.01 ± 8.68
Monocytes, Change from baseline to 8 weeks-0.19 ± 3.68-0.37 ± 2.36
Monocytes, Change from baseline to 16 weeks-0.43 ± 2.81-0.12 ± 1.61
Monocytes, Change from baseline to 24 weeks-0.23 ± 2.88-0.39 ± 1.95
Eosinophils, Change from baseline to 8 weeks-0.25 ± 2.86-0.30 ± 1.35
Eosinophils, Change from baseline to 16 weeks0.07 ± 2.56-0.82 ± 1.86
Eosinophils, Change from baseline to 24 weeks-0.16 ± 2.67-0.67 ± 2.13
Basophils, Change from baseline to 8 weeks-0.02 ± 0.69-0.06 ± 0.75
Basophils, Change from baseline to 16 weeks0.23 ± 0.540.14 ± 0.64
Basophils, Change from baseline to 24 weeks0.00 ± 0.640.07 ± 0.87
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · grams per deciliter
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
grams per deciliterUbiquinolPlacebo
Change from baseline to 8 weeks0.18 ± 1.560.05 ± 0.80
Change from baseline to 16 weeks0.17 ± 1.59-0.25 ± 0.91
Change from baseline to 24 weeks0.10 ± 1.52-0.28 ± 1.11
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · percentage of red blood cells in blood
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
percentage of red blood cells in bloodUbiquinolPlacebo
Change from baseline to 8 weeks0.73 ± 4.640.11 ± 2.58
Change from baseline to 16 weeks0.63 ± 4.94-0.27 ± 3.41
Change from baseline to 24 weeks0.53 ± 4.77-0.25 ± 3.08
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · mIU/L
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
mIU/LUbiquinolPlacebo
Change from Baseline to Week 80.344 ± 1.260.09 ± 0.96
Change from Baseline to Week 160.15 ± 1.31-0.06 ± 0.68
Change from Baseline to Week 24-0.10 ± 1.23-0.04 ± 0.92
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · pg/mL
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
pg/mLUbiquinolPlacebo
Change from Baseline to Week 8-0.06 ± 0.48-0.04 ± 0.29
Change from Baseline to Week 16-0.13 ± 0.48-0.10 ± 0.32
Change from Baseline to Week 24-0.05 ± 0.56-0.17 ± 0.40
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · ng/dL
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
ng/dLUbiquinolPlacebo
Change from Baseline to Week 8-0.00 ± 0.21-0.03 ± 0.11
Change from Baseline to Week 16-0.01 ± 0.19-0.02 ± 0.10
Change from Baseline to Week 24-0.02 ± 0.18-0.06 ± 0.12
SecondaryResponse to Therapy on Cortisol Levels

Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.

Time frame:
Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.
Reported as:
Mean · micrograms/dL
Response to Therapy on Cortisol Levels
micrograms/dLUbiquinolPlacebo
Waking, Change from Baseline to Week 8-0.04 ± 0.32-0.04 ± 0.28
Morning, Change from Baseline to Week 80.04 ± 0.100.10 ± 0.49
Evening, Change from Baseline to Week 8-0.02 ± 0.150.05 ± 0.19
Sleep, Change from Baseline to Week 80.03 ± 0.170.05 ± 0.23
Waking, Change from Baseline to Week 160.08 ± 0.630.02 ± 0.29
Morning, Change from Baseline to Week 160.12 ± 0.53-0.02 ± 0.09
Evening, Change from Baseline to Week 160.03 ± 0.210.05 ± 0.21
Sleep, Change from Baseline to Week 160.11 ± 0.210.01 ± 0.13
Waking, Change from Baseline to Week 240.06 ± 0.240.03 ± 0.17
Morning, Change from Baseline to Week 240.02 ± 0.160.03 ± 0.12
Evening, Change from Baseline to Week 24-0.01 ± 0.160.00 ± 0.12
Sleep, Change from Baseline to Week 240.01 ± 0.15-0.02 ± 0.11
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · ng/mL
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
ng/mLUbiquinolPlacebo
Change from Baseline to Week 8-0.12 ± 2.04-0.14 ± 0.95
Change from Baseline to Week 16-0.19 ± 1.99-0.39 ± 0.75
Change from Baseline to Week 24-0.13 ± 2.08-0.53 ± 1.30
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · ng/mL
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
ng/mLUbiquinolPlacebo
Change from Baseline to Week 80.01 ± 0.160.00 ± 0.09
Change from Baseline to Week 16-0.00 ± 0.16-0.03 ± 0.08
Change from Baseline to Week 24-0.02 ± 0.13-0.05 ± 0.06
SecondaryResponse 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.

Time frame:
Baseline, Weeks 8, 16, and 24
Reported as:
Mean · pg/mL
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
pg/mLUbiquinolPlacebo
Change from Baseline to Week 86.06 ± 25.641.77 ± 7.51
Change from Baseline to Week 16-0.97 ± 11.86-1.37 ± 6.55
Change from Baseline to Week 246.21 ± 27.90-2.19 ± 8.79

Adverse events

Collected over 28 weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ubiquinol0/51 (0%)0/51 (0%)0/51 (0%)
Placebo0/49 (0%)0/49 (0%)0/49 (0%)

Baseline characteristics

Number of all participants for whom baseline characteristics were measured, in each arm/group and in the entire study population (total).

Age, Continuous
Age, Continuous(years)UbiquinolPlaceboTotal
Mean54 ± 653 ± 554 ± 5
Sex: Female, Male
Sex: Female, Male(Participants)UbiquinolPlaceboTotal
Female538
Male464692
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)UbiquinolPlaceboTotal
Hispanic or Latino101222
Not Hispanic or Latino413677
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UbiquinolPlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American121224
White273259
More than one race11314
Unknown or Not Reported123
SF 36 Physical Component Summary (PCS)
SF 36 Physical Component Summary (PCS)(units on a scale)UbiquinolPlaceboTotal
Mean55 ± 2356 ± 2256 ± 22
08

Study locations

4 sites
  • Miami VA Healthcare System, Miami, FL
    Miami, Florida 33125, United States
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    Boston, Massachusetts 02130, United States
  • Minneapolis VA Health Care System, Minneapolis, MN
    Minneapolis, Minnesota 55417, United States
  • James J. Peters VA Medical Center, Bronx, NY
    Bronx, New York 10468, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 19, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02865460
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 12, 2016
Start date
Jul 24, 2017
Primary completion
Oct 7, 2020
Completion
Dec 31, 2020
Results posted
Feb 15, 2023
Last update
Feb 15, 2023

Study contacts

Nancy G Klimas, BS MD
principal investigator · Miami VA Healthcare System, Miami, FL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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