Back to resultsCoenzyme Q10 Phase III Trial in Gulf War Illness
Primary Purpose
Gulf War Illness, Chronic Fatigue, Ubiquinol
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ubiquinol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gulf War Illness focused on measuring 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
Eligibility Criteria
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:
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.
Sites / Locations
- Miami VA Healthcare System, Miami, FL
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Minneapolis VA Health Care System, Minneapolis, MN
- James J. Peters VA Medical Center, Bronx, NY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ubiquinol
Placebo
Arm Description
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Brief Pain Inventory
The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Davidson Trauma Scale
Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Response to Therapy on Cortisol Levels
Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.
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.
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.
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.
Full Information
NCT ID
NCT02865460
First Posted
July 28, 2016
Last Updated
February 10, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02865460
Brief Title
Coenzyme Q10 Phase III Trial in Gulf War Illness
Official Title
A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gulf War Illness, Chronic Fatigue, Ubiquinol, Coenzyme Q10
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ubiquinol
Arm Type
Experimental
Arm Description
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking
Intervention Type
Drug
Intervention Name(s)
Ubiquinol
Other Intervention Name(s)
Coenzyme Q10, CoQ10
Intervention Description
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill, inactive substance
Intervention Description
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Primary Outcome Measure Information:
Title
Veterans Short Form 36-Item Health Survey Physical Component Summary
Description
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 Outcome Measure Information:
Title
Multidimensional Fatigue Inventory (MFI)
Description
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
Title
Gulf War Illness Health Symptom Checklist
Description
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
Title
Brief Pain Inventory
Description
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
Title
Pittsburgh Sleep Quality Index
Description
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
Title
Hamilton Anxiety Scale (HAM-A)
Description
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
Title
Hamilton Depression Scale (HAM-D)
Description
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
Title
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Description
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
Title
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
Description
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
Title
Connors Continuous Performance Test (CPT-3):Omissions T-score
Description
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
Title
Connors Continuous Performance Test (CPT-3):Commissions T-score
Description
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
Title
Brief Visual Memory Test (BVMT): Delayed Recall
Description
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
Title
Brief Visual Memory Test (BVMT): Percent Retained
Description
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
Title
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
Description
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
Title
California Verbal Learning Test (CVLT-II): Short Delay
Description
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
Title
California Verbal Learning Test (CVLT-II): Long Delay Test
Description
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
Title
Davidson Trauma Scale
Description
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
Title
FitBit Sleep Measurement - Total Sleep
Description
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
Title
FitBit Sleep Measurement - Types of Sleep
Description
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
Title
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Description
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
Title
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
Description
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
Title
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Description
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
Title
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Description
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
Title
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Description
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
Title
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Description
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
Title
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Description
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
Title
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Description
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
Title
Response to Therapy on Cortisol Levels
Description
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.
Title
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
Description
HPG will measure testosterone. Average values fell within the normal range for this type of assay.
Time Frame
Baseline, Weeks 8, 16, and 24
Title
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
Description
HPG will measure progesterone. Average values fell within the normal range for this type of assay.
Time Frame
Baseline, Weeks 8, 16, and 24
Title
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
Description
HPG will measure estradiol. Average values fell within the normal range for this type of assay.
Time Frame
Baseline, Weeks 8, 16, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy G Klimas, BS MD
Organizational Affiliation
Miami VA Healthcare System, Miami, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coenzyme Q10 Phase III Trial in Gulf War Illness
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