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Trial Outcomes & Findings for Coenzyme Q10 Phase III Trial in Gulf War Illness (NCT NCT02865460)

NCT ID: NCT02865460

Last Updated: 2023-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Baseline, Weeks 4, 8, 12, 16, 20, and 24

Results posted on

2023-02-15

Participant Flow

Participant milestones

Participant milestones
Measure
Ubiquinol
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Overall Study
STARTED
51
49
Overall Study
COMPLETED
41
43
Overall Study
NOT COMPLETED
10
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Ubiquinol
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Overall Study
Adverse Event
1
0
Overall Study
Withdrawal by Subject
1
1
Overall Study
Lost to Follow-up
7
4
Overall Study
Ubiquinol group -not deployed to Gulf; Placebo group- ill with COVID
1
1

Baseline Characteristics

Intention-to-treat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Total
n=100 Participants
Total of all reporting groups
Age, Continuous
54 years
STANDARD_DEVIATION 6 • n=99 Participants • Intention-to-treat
53 years
STANDARD_DEVIATION 5 • n=107 Participants • Intention-to-treat
54 years
STANDARD_DEVIATION 5 • n=206 Participants • Intention-to-treat
Sex: Female, Male
Female
5 Participants
n=99 Participants
3 Participants
n=107 Participants
8 Participants
n=206 Participants
Sex: Female, Male
Male
46 Participants
n=99 Participants
46 Participants
n=107 Participants
92 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=99 Participants
12 Participants
n=107 Participants
22 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
n=99 Participants
36 Participants
n=107 Participants
77 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=99 Participants
12 Participants
n=107 Participants
24 Participants
n=206 Participants
Race (NIH/OMB)
White
27 Participants
n=99 Participants
32 Participants
n=107 Participants
59 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
11 Participants
n=99 Participants
3 Participants
n=107 Participants
14 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
SF 36 Physical Component Summary (PCS)
55 units on a scale
STANDARD_DEVIATION 23 • n=99 Participants • Intention-to-treat
56 units on a scale
STANDARD_DEVIATION 22 • n=107 Participants • Intention-to-treat
56 units on a scale
STANDARD_DEVIATION 22 • n=206 Participants • Intention-to-treat

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Intention-to-Treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 4 Weeks
1.6 units on a scale
Standard Deviation 11.1
-1.1 units on a scale
Standard Deviation 10.1
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 8 Weeks
1.4 units on a scale
Standard Deviation 12.7
1.1 units on a scale
Standard Deviation 10.3
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 12 Weeks
1.5 units on a scale
Standard Deviation 15.9
-1.8 units on a scale
Standard Deviation 13.1
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 16 Weeks
2.1 units on a scale
Standard Deviation 14.5
1.8 units on a scale
Standard Deviation 12.4
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 20 Weeks
1.6 units on a scale
Standard Deviation 14.7
0.7 units on a scale
Standard Deviation 14.3
Veterans Short Form 36-Item Health Survey Physical Component Summary
Change Baseline to 24 Weeks
0.7 units on a scale
Standard Deviation 12.5
0.3 units on a scale
Standard Deviation 12.7

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Intention-to-Treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 4 Weeks
-0.6 score on a scale
Standard Deviation 8.3
0.2 score on a scale
Standard Deviation 10
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 8 Weeks
-1.8 score on a scale
Standard Deviation 9.9
0.5 score on a scale
Standard Deviation 8
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 12 Weeks
-1.4 score on a scale
Standard Deviation 10
3.6 score on a scale
Standard Deviation 8.4
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 16 Weeks
-3.2 score on a scale
Standard Deviation 9.5
0.3 score on a scale
Standard Deviation 8.1
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 20 Weeks
-0.5 score on a scale
Standard Deviation 7.5
2.5 score on a scale
Standard Deviation 9.0
Multidimensional Fatigue Inventory (MFI)
Change Baseline to 24 Weeks
-2.3 score on a scale
Standard Deviation 9.7
0.8 score on a scale
Standard Deviation 8.7

SECONDARY outcome

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

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Gulf War Illness Health Symptom Checklist
Change from baseline to 4 weeks
-3.7 units on a scale
Standard Deviation 8.8
-2.0 units on a scale
Standard Deviation 6.3
Gulf War Illness Health Symptom Checklist
Change from baseline to 8 weeks
-3.7 units on a scale
Standard Deviation 7.5
-2.6 units on a scale
Standard Deviation 9.4
Gulf War Illness Health Symptom Checklist
Change from baseline to 12 weeks
-5.8 units on a scale
Standard Deviation 10.8
-2.7 units on a scale
Standard Deviation 9.4
Gulf War Illness Health Symptom Checklist
Change from baseline to 16 weeks
-4.6 units on a scale
Standard Deviation 9.5
-1.6 units on a scale
Standard Deviation 6.1
Gulf War Illness Health Symptom Checklist
Change from baseline to 20 weeks
-6.1 units on a scale
Standard Deviation 11.9
-3.7 units on a scale
Standard Deviation 10.3
Gulf War Illness Health Symptom Checklist
Change from baseline to 24 weeks
-3.8 units on a scale
Standard Deviation 8.6
-3.1 units on a scale
Standard Deviation 8.0
Gulf War Illness Health Symptom Checklist
Change from baseline to 28 weeks
-8.7 units on a scale
Standard Deviation 11.5
-9.4 units on a scale
Standard Deviation 13.3

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Intention-to-treat

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

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Brief Pain Inventory
Change from baseline to 4 weeks
0 units on a scale
Standard Deviation 1.1
0 units on a scale
Standard Deviation 1.3
Brief Pain Inventory
Change from baseline to 8 weeks
-0.1 units on a scale
Standard Deviation 1.6
0.3 units on a scale
Standard Deviation 1.6
Brief Pain Inventory
Change from baseline to 12 weeks
0.3 units on a scale
Standard Deviation 1.7
0.3 units on a scale
Standard Deviation 1.6
Brief Pain Inventory
Change from baseline to 16 weeks
-0.1 units on a scale
Standard Deviation 1.8
0.1 units on a scale
Standard Deviation 1.4
Brief Pain Inventory
Change from baseline to 20 weeks
0.2 units on a scale
Standard Deviation 1.6
0.6 units on a scale
Standard Deviation 1.8
Brief Pain Inventory
Change from baseline to 24 weeks
-0.3 units on a scale
Standard Deviation 1.4
-0.3 units on a scale
Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Pittsburgh Sleep Quality Index
Change from baseline to 4 weeks
-1.0 units on a scale
Standard Deviation 2.8
0.0 units on a scale
Standard Deviation 3.1
Pittsburgh Sleep Quality Index
Change from baseline to 8 weeks
-1.2 units on a scale
Standard Deviation 2.9
-0.4 units on a scale
Standard Deviation 2.8
Pittsburgh Sleep Quality Index
Change from baseline to 12 weeks
-1.7 units on a scale
Standard Deviation 3.4
0.1 units on a scale
Standard Deviation 3.6
Pittsburgh Sleep Quality Index
Change from baseline to 16 weeks
-1.6 units on a scale
Standard Deviation 3.0
-1.0 units on a scale
Standard Deviation 3.0
Pittsburgh Sleep Quality Index
Change from baseline to 20 weeks
-0.3 units on a scale
Standard Deviation 3.7
0.3 units on a scale
Standard Deviation 3.7
Pittsburgh Sleep Quality Index
Change from baseline to 24 weeks
-1.4 units on a scale
Standard Deviation 3.5
-0.4 units on a scale
Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Hamilton Anxiety Scale (HAM-A)
Change from baseline to 8 weeks
-0.9 units on a scale
Standard Deviation 9.3
1.7 units on a scale
Standard Deviation 10.3
Hamilton Anxiety Scale (HAM-A)
Change from baseline to 16 weeks
-0.7 units on a scale
Standard Deviation 8.3
-1.7 units on a scale
Standard Deviation 8.3
Hamilton Anxiety Scale (HAM-A)
Change from baseline to 24 weeks
-1.5 units on a scale
Standard Deviation 9.0
0.1 units on a scale
Standard Deviation 10.3

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Hamilton Depression Scale (HAM-D)
Change from baseline to 8 weeks
-2.4 units on a scale
Standard Deviation 6.1
-1.3 units on a scale
Standard Deviation 4.9
Hamilton Depression Scale (HAM-D)
Change from baseline to 16 weeks
-2.8 units on a scale
Standard Deviation 5.8
-3.6 units on a scale
Standard Deviation 4.5
Hamilton Depression Scale (HAM-D)
Change from baseline to 24 weeks
-2.5 units on a scale
Standard Deviation 7.0
-2.8 units on a scale
Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 4 weeks
4.5 score on a scale
Standard Deviation 12.6
0.4 score on a scale
Standard Deviation 12.8
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 8 weeks
4.2 score on a scale
Standard Deviation 14.9
3.6 score on a scale
Standard Deviation 14.8
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 12 weeks
4.0 score on a scale
Standard Deviation 19.5
2.8 score on a scale
Standard Deviation 10.6
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 16 weeks
3.8 score on a scale
Standard Deviation 15.5
4.9 score on a scale
Standard Deviation 13.9
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 20 weeks
-3.7 score on a scale
Standard Deviation 17.4
3.1 score on a scale
Standard Deviation 15.8
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Change from baseline to 24 weeks
2.6 score on a scale
Standard Deviation 16.3
1.1 score on a scale
Standard Deviation 13.5

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
Change from baseline to 8 weeks
10.7 score on a scale
Standard Deviation 43.1
-1.6 score on a scale
Standard Deviation 34.3
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
Change from baseline to 16 weeks
17.2 score on a scale
Standard Deviation 46.9
-3.0 score on a scale
Standard Deviation 49
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
Change from baseline to 24 weeks
24.0 score on a scale
Standard Deviation 46.9
12.8 score on a scale
Standard Deviation 45.4

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Connors Continuous Performance Test (CPT-3):Omissions T-score
Change from baseline to 8 weeks
-2.0 T-score
Standard Deviation 7.6
-1.2 T-score
Standard Deviation 5.2
Connors Continuous Performance Test (CPT-3):Omissions T-score
Change from baseline to 16 weeks
0.2 T-score
Standard Deviation 9.1
-1.6 T-score
Standard Deviation 8.5
Connors Continuous Performance Test (CPT-3):Omissions T-score
Change from baseline to 24 weeks
-0.4 T-score
Standard Deviation 9.1
-1.6 T-score
Standard Deviation 7.8

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Connors Continuous Performance Test (CPT-3):Commissions T-score
Change from baseline to 8 weeks
-3.2 T-score
Standard Deviation 8.0
-2.0 T-score
Standard Deviation 5.3
Connors Continuous Performance Test (CPT-3):Commissions T-score
Change from baseline to 16 weeks
-3.2 T-score
Standard Deviation 8.6
-3.0 T-score
Standard Deviation 6.7
Connors Continuous Performance Test (CPT-3):Commissions T-score
Change from baseline to 24 weeks
-3.5 T-score
Standard Deviation 8.8
-4.5 T-score
Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Brief Visual Memory Test (BVMT): Delayed Recall
Change from baseline to8 weeks
0.3 score on a scale
Standard Deviation 2.3
0.3 score on a scale
Standard Deviation 2.4
Brief Visual Memory Test (BVMT): Delayed Recall
Change from baseline to 16 weeks
0.3 score on a scale
Standard Deviation 2.8
0.9 score on a scale
Standard Deviation 2.0
Brief Visual Memory Test (BVMT): Delayed Recall
Change from baseline to 24 weeks
0.4 score on a scale
Standard Deviation 2.7
0.4 score on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Brief Visual Memory Test (BVMT): Percent Retained
Change from baseline to 8 weeks
-4.1 score on a scale
Standard Deviation 42.9
13.7 score on a scale
Standard Deviation 43
Brief Visual Memory Test (BVMT): Percent Retained
Change from baseline to 16 weeks
-5.6 score on a scale
Standard Deviation 24.6
1.1 score on a scale
Standard Deviation 24.7
Brief Visual Memory Test (BVMT): Percent Retained
Change from baseline to 24 weeks
-0.4 score on a scale
Standard Deviation 52.3
0.4 score on a scale
Standard Deviation 39.4

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
Change from baseline to 8 weeks
0.4 score on a scale
Standard Deviation 7.0
0.9 score on a scale
Standard Deviation 9.8
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
Change from baseline to 16 weeks
4.0 score on a scale
Standard Deviation 8.4
6.7 score on a scale
Standard Deviation 7.5
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
Change from baseline to 24 weeks
5.8 score on a scale
Standard Deviation 8.8
6.9 score on a scale
Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
California Verbal Learning Test (CVLT-II): Short Delay
Change from baseline to 8 weeks
0.2 units on a scale
Standard Deviation 3.0
0.5 units on a scale
Standard Deviation 2.4
California Verbal Learning Test (CVLT-II): Short Delay
Change from baseline to 16 weeks
1.1 units on a scale
Standard Deviation 2.5
1.5 units on a scale
Standard Deviation 1.9
California Verbal Learning Test (CVLT-II): Short Delay
Change from baseline to 24 weeks
1.1 units on a scale
Standard Deviation 2.6
1.5 units on a scale
Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
California Verbal Learning Test (CVLT-II): Long Delay Test
Change from baseline to 8 weeks
-0.4 score on a scale
Standard Deviation 3.7
0.6 score on a scale
Standard Deviation 2.7
California Verbal Learning Test (CVLT-II): Long Delay Test
Change from baseline to 16 weeks
0.3 score on a scale
Standard Deviation 3.6
1.6 score on a scale
Standard Deviation 2.8
California Verbal Learning Test (CVLT-II): Long Delay Test
Change from baseline to 24 weeks
0.9 score on a scale
Standard Deviation 2.9
1.4 score on a scale
Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Davidson Trauma Scale
Change from baseline to 8 weeks
-7.6 score on a scale
Standard Deviation 24.6
-6.7 score on a scale
Standard Deviation 23.4
Davidson Trauma Scale
Change from baseline to 16 weeks
-5.4 score on a scale
Standard Deviation 24.0
-12.1 score on a scale
Standard Deviation 26.5
Davidson Trauma Scale
Change from baseline to 24 weeks
-13.3 score on a scale
Standard Deviation 18.9
-9.4 score on a scale
Standard Deviation 21.8

SECONDARY outcome

Timeframe: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
FitBit Sleep Measurement - Total Sleep
Average Total Sleep, Baseline to Week 8
344.14 minutes
Standard Deviation 54.6
343.4 minutes
Standard Deviation 59.8
FitBit Sleep Measurement - Total Sleep
Average Total Sleep, Week 8 to Week 16
346.31 minutes
Standard Deviation 60.85
348.15 minutes
Standard Deviation 57.57
FitBit Sleep Measurement - Total Sleep
Average Total Sleep, Week 16 to Week 24
350.98 minutes
Standard Deviation 58.28
334.22 minutes
Standard Deviation 70.86

SECONDARY outcome

Timeframe: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
FitBit Sleep Measurement - Types of Sleep
Asleep, Baseline to Week 8
89.06 average percentage of total time in bed
Standard Deviation 2.61
88.57 average percentage of total time in bed
Standard Deviation 1.4
FitBit Sleep Measurement - Types of Sleep
Asleep, Week 8 to Week 16
89.1 average percentage of total time in bed
Standard Deviation 2.6
88.5 average percentage of total time in bed
Standard Deviation 1.36
FitBit Sleep Measurement - Types of Sleep
Asleep, Week 16 to Week 24
88.81 average percentage of total time in bed
Standard Deviation 3.48
88.85 average percentage of total time in bed
Standard Deviation 2.06
FitBit Sleep Measurement - Types of Sleep
Awake, Baseline to Week 8
10.68 average percentage of total time in bed
Standard Deviation 2.71
11.34 average percentage of total time in bed
Standard Deviation 1.37
FitBit Sleep Measurement - Types of Sleep
Awake, Week 8 to Week 16
10.64 average percentage of total time in bed
Standard Deviation 4.28
11.43 average percentage of total time in bed
Standard Deviation 1.92
FitBit Sleep Measurement - Types of Sleep
Awake, Week 16 to Week 24
10.92 average percentage of total time in bed
Standard Deviation 3.28
11.09 average percentage of total time in bed
Standard Deviation 2.06
FitBit Sleep Measurement - Types of Sleep
Light Sleep, Baseline to Week 8
65.37 average percentage of total time in bed
Standard Deviation 6.23
64.68 average percentage of total time in bed
Standard Deviation 7.21
FitBit Sleep Measurement - Types of Sleep
Light Sleep, Week 8 to Week 16
67.31 average percentage of total time in bed
Standard Deviation 6.43
65.89 average percentage of total time in bed
Standard Deviation 7.1
FitBit Sleep Measurement - Types of Sleep
Light Sleep, Week 16 to Week 24
64.49 average percentage of total time in bed
Standard Deviation 6.04
65.28 average percentage of total time in bed
Standard Deviation 7.98
FitBit Sleep Measurement - Types of Sleep
Deep Sleep, Baseline to Week 8
15.29 average percentage of total time in bed
Standard Deviation 3.62
14.7 average percentage of total time in bed
Standard Deviation 5.97
FitBit Sleep Measurement - Types of Sleep
Deep Sleep, Week 8 to Week 16
14.04 average percentage of total time in bed
Standard Deviation 3.97
13.82 average percentage of total time in bed
Standard Deviation 5.48
FitBit Sleep Measurement - Types of Sleep
Deep Sleep, Week 16 to Week 24
15.78 average percentage of total time in bed
Standard Deviation 3.57
15.23 average percentage of total time in bed
Standard Deviation 5.86
FitBit Sleep Measurement - Types of Sleep
REM Sleep, Baseline to Week 8
19.33 average percentage of total time in bed
Standard Deviation 3.86
6.41 average percentage of total time in bed
Standard Deviation 1.31
FitBit Sleep Measurement - Types of Sleep
REM Sleep, Week 8 to Week 16
18.65 average percentage of total time in bed
Standard Deviation 4.38
20.21 average percentage of total time in bed
Standard Deviation 3.43
FitBit Sleep Measurement - Types of Sleep
REM Sleep, Week 16 to Week 24
19.74 average percentage of total time in bed
Standard Deviation 3.98
18.75 average percentage of total time in bed
Standard Deviation 4.59

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
WBC, Change from baseline to 8 weeks
0.41 1000 cells per microliter
Standard Deviation 2.63
0.34 1000 cells per microliter
Standard Deviation 1.27
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
WBC, Change from baseline to 16 weeks
0.22 1000 cells per microliter
Standard Deviation 2.54
0.14 1000 cells per microliter
Standard Deviation 1.27
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
WBC, Change from baseline to 24 weeks
0.22 1000 cells per microliter
Standard Deviation 2.81
0.44 1000 cells per microliter
Standard Deviation 1.44
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Platelets, Change from baseline to 8 weeks
-0.94 1000 cells per microliter
Standard Deviation 74.64
-2.00 1000 cells per microliter
Standard Deviation 26.20
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Platelets, Change from baseline to 16 weeks
-5.88 1000 cells per microliter
Standard Deviation 79.94
3.74 1000 cells per microliter
Standard Deviation 31.36
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Platelets, Change from baseline to 24 weeks
-6.00 1000 cells per microliter
Standard Deviation 78.07
14.48 1000 cells per microliter
Standard Deviation 48.81

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
RBC, Change from baseline to 8 weeks
0.10 1000000 cells per microliter
Standard Deviation 0.64
0.01 1000000 cells per microliter
Standard Deviation 0.27
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
RBC, Change from baseline to 16 weeks
0.12 1000000 cells per microliter
Standard Deviation 0.70
-0.03 1000000 cells per microliter
Standard Deviation 0.33
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
RBC, Change from baseline to 24 weeks
0.08 1000000 cells per microliter
Standard Deviation 0.69
-0.02 1000000 cells per microliter
Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Neutrophils, Change from baseline to 8 weeks
2.08 percentage of white blood cells
Standard Deviation 15.11
1.13 percentage of white blood cells
Standard Deviation 9.25
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Neutrophils, Change from baseline to 16 weeks
0.26 percentage of white blood cells
Standard Deviation 13.97
0.74 percentage of white blood cells
Standard Deviation 9.36
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Neutrophils, Change from baseline to 24 weeks
3.33 percentage of white blood cells
Standard Deviation 14.81
2.04 percentage of white blood cells
Standard Deviation 10.95
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Lymphocytes, Change from baseline to 8 weeks
-1.64 percentage of white blood cells
Standard Deviation 12.29
-0.39 percentage of white blood cells
Standard Deviation 7.83
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Lymphocytes, Change from baseline to 16 weeks
-0.18 percentage of white blood cells
Standard Deviation 12.73
0.10 percentage of white blood cells
Standard Deviation 7.66
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Lymphocytes, Change from baseline to 24 weeks
-3.01 percentage of white blood cells
Standard Deviation 13.22
-1.01 percentage of white blood cells
Standard Deviation 8.68
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Monocytes, Change from baseline to 8 weeks
-0.19 percentage of white blood cells
Standard Deviation 3.68
-0.37 percentage of white blood cells
Standard Deviation 2.36
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Monocytes, Change from baseline to 16 weeks
-0.43 percentage of white blood cells
Standard Deviation 2.81
-0.12 percentage of white blood cells
Standard Deviation 1.61
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Monocytes, Change from baseline to 24 weeks
-0.23 percentage of white blood cells
Standard Deviation 2.88
-0.39 percentage of white blood cells
Standard Deviation 1.95
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Eosinophils, Change from baseline to 8 weeks
-0.25 percentage of white blood cells
Standard Deviation 2.86
-0.30 percentage of white blood cells
Standard Deviation 1.35
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Eosinophils, Change from baseline to 16 weeks
0.07 percentage of white blood cells
Standard Deviation 2.56
-0.82 percentage of white blood cells
Standard Deviation 1.86
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Eosinophils, Change from baseline to 24 weeks
-0.16 percentage of white blood cells
Standard Deviation 2.67
-0.67 percentage of white blood cells
Standard Deviation 2.13
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Basophils, Change from baseline to 8 weeks
-0.02 percentage of white blood cells
Standard Deviation 0.69
-0.06 percentage of white blood cells
Standard Deviation 0.75
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Basophils, Change from baseline to 16 weeks
0.23 percentage of white blood cells
Standard Deviation 0.54
0.14 percentage of white blood cells
Standard Deviation 0.64
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Basophils, Change from baseline to 24 weeks
0.00 percentage of white blood cells
Standard Deviation 0.64
0.07 percentage of white blood cells
Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Change from baseline to 8 weeks
0.18 grams per deciliter
Standard Deviation 1.56
0.05 grams per deciliter
Standard Deviation 0.80
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Change from baseline to 16 weeks
0.17 grams per deciliter
Standard Deviation 1.59
-0.25 grams per deciliter
Standard Deviation 0.91
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Change from baseline to 24 weeks
0.10 grams per deciliter
Standard Deviation 1.52
-0.28 grams per deciliter
Standard Deviation 1.11

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Change from baseline to 8 weeks
0.73 percentage of red blood cells in blood
Standard Deviation 4.64
0.11 percentage of red blood cells in blood
Standard Deviation 2.58
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Change from baseline to 16 weeks
0.63 percentage of red blood cells in blood
Standard Deviation 4.94
-0.27 percentage of red blood cells in blood
Standard Deviation 3.41
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Change from baseline to 24 weeks
0.53 percentage of red blood cells in blood
Standard Deviation 4.77
-0.25 percentage of red blood cells in blood
Standard Deviation 3.08

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Change from Baseline to Week 8
0.344 mIU/L
Standard Deviation 1.26
0.09 mIU/L
Standard Deviation 0.96
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Change from Baseline to Week 16
0.15 mIU/L
Standard Deviation 1.31
-0.06 mIU/L
Standard Deviation 0.68
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Change from Baseline to Week 24
-0.10 mIU/L
Standard Deviation 1.23
-0.04 mIU/L
Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Change from Baseline to Week 8
-0.06 pg/mL
Standard Deviation 0.48
-0.04 pg/mL
Standard Deviation 0.29
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Change from Baseline to Week 16
-0.13 pg/mL
Standard Deviation 0.48
-0.10 pg/mL
Standard Deviation 0.32
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Change from Baseline to Week 24
-0.05 pg/mL
Standard Deviation 0.56
-0.17 pg/mL
Standard Deviation 0.40

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Change from Baseline to Week 8
-0.00 ng/dL
Standard Deviation 0.21
-0.03 ng/dL
Standard Deviation 0.11
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Change from Baseline to Week 16
-0.01 ng/dL
Standard Deviation 0.19
-0.02 ng/dL
Standard Deviation 0.10
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Change from Baseline to Week 24
-0.02 ng/dL
Standard Deviation 0.18
-0.06 ng/dL
Standard Deviation 0.12

SECONDARY outcome

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

Population: Intention-to-treat

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

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Cortisol Levels
Waking, Change from Baseline to Week 8
-0.04 micrograms/dL
Standard Deviation 0.32
-0.04 micrograms/dL
Standard Deviation 0.28
Response to Therapy on Cortisol Levels
Morning, Change from Baseline to Week 8
0.04 micrograms/dL
Standard Deviation 0.10
0.10 micrograms/dL
Standard Deviation 0.49
Response to Therapy on Cortisol Levels
Evening, Change from Baseline to Week 8
-0.02 micrograms/dL
Standard Deviation 0.15
0.05 micrograms/dL
Standard Deviation 0.19
Response to Therapy on Cortisol Levels
Sleep, Change from Baseline to Week 8
0.03 micrograms/dL
Standard Deviation 0.17
0.05 micrograms/dL
Standard Deviation 0.23
Response to Therapy on Cortisol Levels
Waking, Change from Baseline to Week 16
0.08 micrograms/dL
Standard Deviation 0.63
0.02 micrograms/dL
Standard Deviation 0.29
Response to Therapy on Cortisol Levels
Morning, Change from Baseline to Week 16
0.12 micrograms/dL
Standard Deviation 0.53
-0.02 micrograms/dL
Standard Deviation 0.09
Response to Therapy on Cortisol Levels
Evening, Change from Baseline to Week 16
0.03 micrograms/dL
Standard Deviation 0.21
0.05 micrograms/dL
Standard Deviation 0.21
Response to Therapy on Cortisol Levels
Sleep, Change from Baseline to Week 16
0.11 micrograms/dL
Standard Deviation 0.21
0.01 micrograms/dL
Standard Deviation 0.13
Response to Therapy on Cortisol Levels
Waking, Change from Baseline to Week 24
0.06 micrograms/dL
Standard Deviation 0.24
0.03 micrograms/dL
Standard Deviation 0.17
Response to Therapy on Cortisol Levels
Morning, Change from Baseline to Week 24
0.02 micrograms/dL
Standard Deviation 0.16
0.03 micrograms/dL
Standard Deviation 0.12
Response to Therapy on Cortisol Levels
Evening, Change from Baseline to Week 24
-0.01 micrograms/dL
Standard Deviation 0.16
0.00 micrograms/dL
Standard Deviation 0.12
Response to Therapy on Cortisol Levels
Sleep, Change from Baseline to Week 24
0.01 micrograms/dL
Standard Deviation 0.15
-0.02 micrograms/dL
Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

HPG will measure testosterone. Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
Change from Baseline to Week 8
-0.12 ng/mL
Standard Deviation 2.04
-0.14 ng/mL
Standard Deviation 0.95
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
Change from Baseline to Week 16
-0.19 ng/mL
Standard Deviation 1.99
-0.39 ng/mL
Standard Deviation 0.75
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
Change from Baseline to Week 24
-0.13 ng/mL
Standard Deviation 2.08
-0.53 ng/mL
Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

HPG will measure progesterone. Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
Change from Baseline to Week 8
0.01 ng/mL
Standard Deviation 0.16
0.00 ng/mL
Standard Deviation 0.09
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
Change from Baseline to Week 16
-0.00 ng/mL
Standard Deviation 0.16
-0.03 ng/mL
Standard Deviation 0.08
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
Change from Baseline to Week 24
-0.02 ng/mL
Standard Deviation 0.13
-0.05 ng/mL
Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, and 24

Population: Intention-to-treat

HPG will measure estradiol. Average values fell within the normal range for this type of assay.

Outcome measures

Outcome measures
Measure
Ubiquinol
n=51 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
n=49 Participants
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
Change from Baseline to Week 8
6.06 pg/mL
Standard Deviation 25.64
1.77 pg/mL
Standard Deviation 7.51
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
Change from Baseline to Week 16
-0.97 pg/mL
Standard Deviation 11.86
-1.37 pg/mL
Standard Deviation 6.55
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
Change from Baseline to Week 24
6.21 pg/mL
Standard Deviation 27.90
-2.19 pg/mL
Standard Deviation 8.79

Adverse Events

Ubiquinol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Klimas, MD

Miami VA Healthcare System

Phone: 305-575-7000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place