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NCT02865460·Phase 3·INTERVENTIONAL

Coenzyme Q10 Phase III Trial in Gulf War Illness

GanirelixInflammationPainBrain healthCompleted

Status

Completed

Phase

Phase 3

Enrollment

100

Locations

4

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Ubiquinol

Take oral tablets as directed (2x200 mg for 2 months; 1x200 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

Timeline

From registration to results.

  1. First posted

    Aug 12, 2016

  2. Study start

    Jul 24, 2017

  3. Primary completion

    Oct 7, 2020

  4. Study completion

    Dec 31, 2020

  5. Results posted

    Feb 15, 2023

  6. Registry updated

    Feb 15, 2023

Outcomes

What the study measures.

Primary outcomes

Veterans Short Form 36-Item Health Survey Physical Component Summary

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

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 outcomes

Multidimensional Fatigue Inventory (MFI)

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

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

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

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

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

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

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

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)

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

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)

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

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)

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

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

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

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

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

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

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

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.

Eligibility

Who can take part.

Minimum age
35 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Male and female Veterans who were deployed in 1990 -1991 Gulf War. * Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness. * Veterans who were in good health based on medical history prior to 1990. * Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36. Exclusion Criteria: * 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.

Study locations

4 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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