Coenzyme Q10 Phase III Trial in Gulf War Illness

NCT ID: NCT02865460

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2020-12-31

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.

Conditions

Gulf War Illness; Chronic Fatigue; Ubiquinol; Coenzyme Q10

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ubiquinol

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

Group Type: EXPERIMENTAL

Ubiquinol

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Ubiquinol

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Coenzyme Q10, CoQ10; Sugar pill, inactive substance

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy G Klimas, BS MD

Role: PRINCIPAL_INVESTIGATOR

Miami VA Healthcare System, Miami, FL

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SPLD-04-15F

Identifier Type: -

Identifier Source: org_study_id