Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Chronic Fatigue Syndrome

In brief

The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective therapy has been developed. Recent studies suggest that a preceding viral infection causes mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible individuals. There is no specific laboratory test to identify patients with CFS. However, certain clinical manifestations are similar to those seen in mitochondrial disorders. Both patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain glutathione levels on nuclear magnetic resonance (NMR) spectroscopy. Therapy consisting of daily conditioning exercise, dietary recommendations, and nutraceutical supplements (ENT) has been show to be beneficial in treating patients with mitochondrial disorders. Similar therapy has been instituted in individual patients with CFS and has been shown to also improve their clinical conditions. A placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical causes for fatigue will be excluded. Half the patients will receive treatment consisting of daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be beneficial for patients with mitochondrial dysfunction, while the other half will receive daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by maximum oxygen consumption (VO2max) and circulating lactate levels during \& after treadmill exercise, a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT corrects the elevated brain cerebrospinal fluid levels and decreased brain glutathione levels will be measured. To ensure compliance to therapy patients will be monitored frequently. The objective of this study is to assess the safety and efficacy of ENT and whether ENT leads to sustained improvement of CFS patients compared to their baseline status, and compared to an exercised group of patients not receiving supplements.

Key facts

Study ID

NCT01471652

Run by

Columbia University

People needed

0

Starts

2012-03-01

Expected to finish

2013-02-01

Last updated by the study team

2015-04-13

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet the criteria for CFS of the US Centers for Disease Control and Prevention (CDC), which requires 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
• post-exertional malaise
• As well, due to the frequency of visits subjects must currently reside in the greater New York area.

You may not qualify if…

• shortness of breath
• heart disease
• high blood pressure
• other severe chronic illnesses
• clinical depression
• generalized anxiety disorder
• insomnia
• inflammatory arthritis
• anemia
• hypothyroidism
• other conditions associated with significant fatigue
• history of alcohol, tobacco, or drug abuse

Where it is running

• Columbia University Department of Clinical Genetics — New York, New York, United States

Full record on ClinicalTrials.gov

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