Coenzyme Q10 Phase III Trial in Gulf War Illness
A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
1 other identifier
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2017
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedStudy Start
First participant enrolled
July 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
February 15, 2023
CompletedFebruary 15, 2023
February 1, 2023
3.2 years
July 28, 2016
July 29, 2022
February 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Veterans Short Form 36-Item Health Survey Physical Component Summary
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.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary Outcomes (30)
Multidimensional Fatigue Inventory (MFI)
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Gulf War Illness Health Symptom Checklist
Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28
Brief Pain Inventory
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Pittsburgh Sleep Quality Index
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Hamilton Anxiety Scale (HAM-A)
Baseline, Weeks 8, 16, and 24
- +25 more secondary outcomes
Study Arms (2)
Ubiquinol
EXPERIMENTALTake oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Placebo
PLACEBO COMPARATORTake oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking
Interventions
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417, United States
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study recruitment closed on 4/1/2020, coinciding with the onset of the COVID-19 pandemic. Participants could not complete their in-person visits due to the closure of VA research services and VA outpatient labs.
Results Point of Contact
- Title
- Nancy Klimas, MD
- Organization
- Miami VA Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy G Klimas, BS MD
Miami VA Healthcare System, Miami, FL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 12, 2016
Study Start
July 24, 2017
Primary Completion
October 7, 2020
Study Completion
December 31, 2020
Last Updated
February 15, 2023
Results First Posted
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share