A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Veterans Short Form 36-Item Health Survey Physical Component Summary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.
排除标准
- •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:
- •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.
研究组 & 干预措施
Ubiquinol
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
干预措施: Ubiquinol (Drug)
Placebo
Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking
干预措施: Placebo (Drug)
结局指标
主要结局
Veterans Short Form 36-Item Health Survey Physical Component Summary
时间窗: 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.
次要结局
- Davidson Trauma Scale(Baseline, Weeks 8, 16, and 24)
- Brief Pain Inventory(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Connors Continuous Performance Test (CPT-3):Omissions T-score(Baseline, Weeks 8, 16, and 24)
- Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3(Baseline, Weeks 8, 16, and 24)
- Hamilton Depression Scale (HAM-D)(Baseline, Weeks 8, 16, and 24)
- FitBit Sleep Measurement - Total Sleep(Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks)
- FitBit Sleep Measurement - Types of Sleep(Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks)
- Gulf War Illness Health Symptom Checklist(Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28)
- Connors Continuous Performance Test (CPT-3): Hit Reaction Time(Baseline, Weeks 8, 16, and 24)
- Multidimensional Fatigue Inventory (MFI)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Connors Continuous Performance Test (CPT-3):Commissions T-score(Baseline, Weeks 8, 16, and 24)
- Brief Visual Memory Test (BVMT): Percent Retained(Baseline, Weeks 8, 16, and 24)
- California Verbal Learning Test (CVLT-II): Long Delay Test(Baseline, Weeks 8, 16, and 24)
- Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts(Baseline, Weeks 8, 16, and 24)
- Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages(Baseline, Weeks 8, 16, and 24)
- Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin(Baseline, Weeks 8, 16, 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)
- Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Brief Visual Memory Test (BVMT): Delayed Recall(Baseline, Weeks 8, 16, and 24)
- California Verbal Learning Test (CVLT-II): Correct Trials # 1-5(Baseline, Weeks 8, 16, and 24)
- California Verbal Learning Test (CVLT-II): Short Delay(Baseline, Weeks 8, 16, and 24)
- Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH(Baseline, Weeks 8, 16, and 24)
- Response to Therapy on Cortisol Levels(Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.)