CoQ10 in Gulf War Illness

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02865460

Collaborator

(none)

100

Enrollment

Locations

Arms

41.3

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gulf War Illness Chronic Fatigue Ubiquinol Coenzyme Q10	Drug: Ubiquinol Drug: Placebo	Phase 3

Detailed Description

As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction Exploratory studies using interventions that support cell functioning and prevent or repair stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing physical functioning for Veterans with Gulf War Illness.

This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness

Actual Study Start Date :

Jul 24, 2017

Actual Primary Completion Date :

Oct 7, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ubiquinol Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking	Drug: Ubiquinol Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Other Names: Coenzyme Q10, CoQ10
Placebo Comparator: Placebo Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking	Drug: Placebo Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking Other Names: Sugar pill, inactive substance

Arm

Intervention/Treatment

Experimental: Ubiquinol

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

Drug: Ubiquinol

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

Other Names:

Coenzyme Q10, CoQ10

Placebo Comparator: Placebo

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

Drug: Placebo

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

Other Names:

Sugar pill, inactive substance

Outcome Measures

Primary Outcome Measures

Veterans Short Form 36-Item Health Survey Physical Component Summary [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view.

Secondary Outcome Measures

Multidimensional Fatigue Inventory (MFI) scores [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
GWI Health Symptom Checklist (HSCI) [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
HSC asks questions about symptoms related to Gulf War Illness.
Brief Pain Inventory [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
This is a linear rating scale of level of pain.
Pittsburgh Sleep Inventory [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
PSI Inventory of sleep and wake cycles completed by participant.
Hamilton Anxiety Scale (HAM-A) [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
This measure allows the participant to rate levels of anxiety.
FitBit activity measurement [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
FitBit measures activity and inactivity periods via a bracelet-type instrument worn on the participant's wrist throughout the study.
Davidson Trauma Scale [Change from Baseline at 8, 16, and 24 weeks]
Davidson Trauma Scale asks questions about stress, arousal, and avoidance.
Connors Continuous Performance Test (CPT-3) [Change from Baseline at 8, 16, and 24 weeks]
CPT-3 asks questions about cognitive symptoms related to attention and reaction time.
California Verbal Learning Test (CVLT-II) [Change from Baseline at 8, 16, and 24 weeks]
CVLT-II asks questions about cognitive symptoms related to recall and memory.
Brief Visual Memory Test (BVMT) [Change from Baseline at 8, 16, and 24 weeks]
BVMT asks questions about cognitive symptoms related to visual memory.
Response to therapy of Gulf War Illness-associated peripheral blood biomarkers [Change from Baseline at 8, 16 and 24 weeks]
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses.
Hamilton Depression Scale (HAM-D) [Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks]
This measure allows the participant to rate level of depression.
Response to therapy on cortisol levels [Change from Baseline at 16 and 24 weeks]
Cortisol will be measured using a 24 hour salivary collection to assess circadian rhythm.
Response to therapy on Hypothalamic-Pituitary-Thyroid (HPT) axis [Change from Baseline at 16 and 24 weeks]
Thyroid status is assessed using a chemoluminescent method (TSH, free T3, free T4).
Response to therapy on Hypothalamic-Pituitary-Gonadal (HPG) axis [Change from Baseline at 16 and 24 weeks]
HPG will measure testosterone (free), FSH, LH, estrogen.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami VA Healthcare System, Miami, FL	Miami	Florida	United States	33125
2	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130
3	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota	United States	55417
4	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York	United States	10468