Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Modified Fatigue Severity Score (FSS-11)
研究概览
简要总结
The purpose of this study is to determine whether therapy that has been shown to be beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS) patients. This study is a chart review of previous CFS patients who received daily conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed nutraceutical supplements included alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.
Twelve CFS male and female patients between the ages of 20-70 years will be recruited to participate in this pilot study. Subjects will be eligible to participate if they meet the criteria for CFS of the Centers for Disease Control and Prevention (CDC). These include persistent, unexplained fatigue for at least 6 months, concurrent with four of the following: impaired memory/concentration, sore throat, new headaches, unrefreshing sleep, muscle pain, multi-joint pain, tender lymph nodes, and post-exertional malaise.
详细描述
The etiology and pathogenesis of chronic fatigue syndrome (CFS) is poorly understood. Although therapies have been proposed, none has been particularly effective. A preceding viral infection is believed to cause mitochondrial dysfunction in genetically susceptible individuals, resulting in overwhelming fatigue, myalgia and brain fuzziness. The purpose of this study was to determine whether therapy that has been shown to be beneficial for mitochondrial diseases is also beneficial for CFS.
Patients received daily conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed nutraceutical supplements incldued alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin, which were selected to enhance mitochondrial function and antioxidant action. Following the institution of ENT, patients had received this therapy for varying lengths of time, ranging from 12 to 40 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe chronic fatigue for 6 or more consecutive months 4 or more of the following 8 symptoms concurrently:
- •post-exertion malaise lasting more than 24 hours
- •unrefreshing sleep
- •significant impairment of short-term memory or concentration
- •muscle pain
- •pain in the joints without swelling or redness
- •headaches of a new type, pattern, or severity
- •tender lymph nodes in the neck or armpit
- •a sore throat that is frequent or recurring These symptoms should have persisted or recurred during 6 or more consecutive months of illness and they cannot have first appeared before the fatigue.
排除标准
- •Additional medical illnesses causing chronic fatigue
- •Ongoing exertion
研究组 & 干预措施
pre and 12 months post ENT
Compare the clinical status of CFS patients after at least 12 months of ENT to their status before ENT.
ENT consists of:
Daily conditioning exercise: 35-40 minutes
Nutraceutical supplements: acetyl-L-carnitine 500 mg bid, alpha-lipoic acid (Alpha Lipoic Sustain 300) 300 mg qd, CoQ10 (Ubiquinol QH-absorb) 100 mg qd, docosahexanoic acid (maxDHA) 300 mg qd, plus a multivitamin (Centrum Silver) ½ tab bid.
Diet: 25% protein, 35- 40% carbohydrate, 35-40% fat
干预措施: Nutraceuticals (Drug)
结局指标
主要结局
Modified Fatigue Severity Score (FSS-11)
时间窗: 6-40 months
次要结局
- Other Symptoms Questionnaire score(6-40 months)