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Trial record 2 of 6 for:    coq10 AND dementia

CoQ10 in Gulf War Illness

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02865460
First received: July 28, 2016
Last updated: August 9, 2016
Last verified: August 2016
  Purpose
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 Intervention Phase
Gulf War Illness
Chronic Fatigue
Ubiquinol
Coenzyme Q10
Drug: Ubiquinol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Veterans Short Form 36-Item Health Survey Physical Component Summary [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.

  • GWI Health Symptom Checklist (HSCI) [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    HSC asks questions about symptoms related to Gulf War Illness.

  • Brief Pain Inventory [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    This is a linear rating scale of level of pain.

  • Pittsburgh Sleep Inventory [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    PSI Inventory of sleep and wake cycles completed by participant.

  • Hamilton Anxiety Scale (HAM-A) [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    This measure allows the participant to rate levels of anxiety.

  • FitBit activity measurement [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    FitBit measures activity and inactivity periods via a bracelet-type instrument worn on the participant's wrist throughout the study.

  • Davidson Trauma Scale [ Time Frame: Change from Baseline at 8, 16, and 24 weeks ] [ Designated as safety issue: No ]
    Davidson Trauma Scale asks questions about stress, arousal, and avoidance.

  • Connors Continuous Performance Test (CPT-3) [ Time Frame: Change from Baseline at 8, 16, and 24 weeks ] [ Designated as safety issue: No ]
    CPT-3 asks questions about cognitive symptoms related to attention and reaction time.

  • California Verbal Learning Test (CVLT-II) [ Time Frame: Change from Baseline at 8, 16, and 24 weeks ] [ Designated as safety issue: No ]
    CVLT-II asks questions about cognitive symptoms related to recall and memory.

  • Brief Visual Memory Test (BVMT) [ Time Frame: Change from Baseline at 8, 16, and 24 weeks ] [ Designated as safety issue: No ]
    BVMT asks questions about cognitive symptoms related to visual memory.

  • Response to therapy of Gulf War Illness-associated peripheral blood biomarkers [ Time Frame: Change from Baseline at 8, 16 and 24 weeks ] [ Designated as safety issue: Yes ]
    Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses.

  • Hamilton Depression Scale (HAM-D) [ Time Frame: Change from Baseline at 4, 8, 12, 16, 20, 24, and 28 weeks ] [ Designated as safety issue: No ]
    This measure allows the participant to rate level of depression.

  • Response to therapy on cortisol levels [ Time Frame: Change from Baseline at 16 and 24 weeks ] [ Designated as safety issue: No ]
    Cortisol will be measured using a 24 hour salivary collection to assess circadian rhythm.

  • Response to therapy on Hypothalamic-Pituitary-Thyroid (HPT) axis [ Time Frame: Change from Baseline at 16 and 24 weeks ] [ Designated as safety issue: No ]
    Thyroid status is assessed using a chemoluminescent method (TSH, free T3, free T4).

  • Response to therapy on Hypothalamic-Pituitary-Gonadal (HPG) axis [ Time Frame: Change from Baseline at 16 and 24 weeks ] [ Designated as safety issue: No ]
    HPG will measure testosterone (free), FSH, LH, estrogen.


Estimated Enrollment: 200
Study Start Date: September 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sugar pill, inactive substance

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • post-traumatic stress disorder (PTSD)
    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02865460

Contacts
Contact: Nancy G Klimas, BS MD (305) 575-3267 Nancy.Klimas@va.gov
Contact: Devra E Cohen (305) 575-7000 ext 3548 Devra.Cohen@va.gov

Locations
United States, Florida
Miami VA Healthcare System, Miami, FL Not yet recruiting
Miami, Florida, United States, 33125
Contact: Nancy G Klimas, BS MD    (305) 575-3267    Nancy.Klimas@va.gov   
Contact: Devra E Cohen    (305) 575-7000 ext 3548    Devra.Cohen@va.gov   
Principal Investigator: Nancy Grace Klimas, BS MD         
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Maxine Krengel, PhD    857-364-6933    maxine.krengel@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Apostolos Georgopoulos, MD    612-725-2282    omega@umn.edu   
Contact: Lisa James, PhD    6124671695    lisa.james2@va.gov   
United States, New York
James J. Peters VA Medical Center, Bronx, NY Not yet recruiting
Bronx, New York, United States, 10468
Contact: Julia Golier, MD    718-584-9000 ext 6587    julia.golier@va.gov   
Contact: Brendan Bechard    7185849000 ext 6587    brendan.bechare@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Nancy Grace Klimas, BS MD Miami VA Healthcare System, Miami, FL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02865460     History of Changes
Other Study ID Numbers: SPLD-04-15F 
Study First Received: July 28, 2016
Last Updated: August 9, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Dementia
Chronic Pain
Cognitive Disorders
Inflammation
Neurologic manifestations
Mental Disorders
Ubiquinol/ubiquinone
Pathologic Processes
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagon
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses
Physiological Effects of Drugs
Gulf war illness
Chronic fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on December 06, 2016