Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder
Status:
Withdrawn
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
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.