Phase 3
N=100
Coenzyme Q10 Phase III Trial in Gulf War Illness
Gulf War Illness · Chronic Fatigue · Ubiquinol · Coenzyme Q10
Bottom Line
View on ClinicalTrials.gov: NCT02865460 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Veterans Short Form 36-Item Health Survey Physical Component Summary — 1.6; -1.1; 1.4; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ubiquinol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Veterans Short Form 36-Item Health Survey Physical Component Summary |
1.6; -1.1; 1.4; 1.1; 1.5; -1.8 | — |
| SECONDARY Multidimensional Fatigue Inventory (MFI) |
-0.6; 0.2; -1.8; 0.5; -1.4; 3.6 | — |
| SECONDARY Gulf War Illness Health Symptom Checklist |
-3.7; -2.0; -3.7; -2.6; -5.8; -2.7 | — |
| SECONDARY Brief Pain Inventory |
0; 0; -0.1; 0.3; 0.3; 0.3 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
-1.0; 0.0; -1.2; -0.4; -1.7; 0.1 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) |
-0.9; 1.7; -0.7; -1.7; -1.5; 0.1 | — |
| SECONDARY Hamilton Depression Scale (HAM-D) |
-2.4; -1.3; -2.8; -3.6; -2.5; -2.8 | — |
| SECONDARY Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) |
4.5; 0.4; 4.2; 3.6; 4.0; 2.8 | — |
| SECONDARY Connors Continuous Performance Test (CPT-3): Hit Reaction Time |
10.7; -1.6; 17.2; -3.0; 24.0; 12.8 | — |
| SECONDARY Connors Continuous Performance Test (CPT-3):Omissions T-score |
-2.0; -1.2; 0.2; -1.6; -0.4; -1.6 | — |
| SECONDARY Connors Continuous Performance Test (CPT-3):Commissions T-score |
-3.2; -2.0; -3.2; -3.0; -3.5; -4.5 | — |
| SECONDARY Brief Visual Memory Test (BVMT): Delayed Recall |
0.3; 0.3; 0.3; 0.9; 0.4; 0.4 | — |
| SECONDARY Brief Visual Memory Test (BVMT): Percent Retained |
-4.1; 13.7; -5.6; 1.1; -0.4; 0.4 | — |
| SECONDARY California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 |
0.4; 0.9; 4.0; 6.7; 5.8; 6.9 | — |
| SECONDARY California Verbal Learning Test (CVLT-II): Short Delay |
0.2; 0.5; 1.1; 1.5; 1.1; 1.5 | — |
| SECONDARY California Verbal Learning Test (CVLT-II): Long Delay Test |
-0.4; 0.6; 0.3; 1.6; 0.9; 1.4 | — |
| SECONDARY Davidson Trauma Scale |
-7.6; -6.7; -5.4; -12.1; -13.3; -9.4 | — |
| SECONDARY FitBit Sleep Measurement - Total Sleep |
344.14; 343.4; 346.31; 348.15; 350.98; 334.22 | — |
| SECONDARY FitBit Sleep Measurement - Types of Sleep |
89.06; 88.57; 89.1; 88.5; 88.81; 88.85 | — |
| SECONDARY Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets |
0.41; 0.34; 0.22; 0.14; 0.22; 0.44 | — |
| SECONDARY Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts |
0.10; 0.01; 0.12; -0.03; 0.08; -0.02 | — |
| SECONDARY Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages |
2.08; 1.13; 0.26; 0.74; 3.33; 2.04 | — |
| SECONDARY Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin |
0.18; 0.05; 0.17; -0.25; 0.10; -0.28 | — |
| SECONDARY Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit |
0.73; 0.11; 0.63; -0.27; 0.53; -0.25 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH |
0.344; 0.09; 0.15; -0.06; -0.10; -0.04 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 |
-0.06; -0.04; -0.13; -0.10; -0.05; -0.17 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 |
-0.00; -0.03; -0.01; -0.02; -0.02; -0.06 | — |
| SECONDARY Response to Therapy on Cortisol Levels |
-0.04; -0.04; 0.04; 0.10; -0.02; 0.05 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone |
-0.12; -0.14; -0.19; -0.39; -0.13; -0.53 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone |
0.01; 0.00; -0.00; -0.03; -0.02; -0.05 | — |
| SECONDARY Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol |
6.06; 1.77; -0.97; -1.37; 6.21; -2.19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02865460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.