Clinical Trial: Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Columbia University

Current Primary Outcome: Modified Fatigue Severity Score (FSS-11) [ Time Frame: 6-40 months ]

Original Primary Outcome: Modified Fatigue Severity Score [ Time Frame: 6-40 months ]

Current Secondary Outcome: Other Symptoms Questionnaire score [ Time Frame: 6-40 months ]

Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score


Original Secondary Outcome: Other Symptoms Questionnaire [ Time Frame: 6-40 months ]

Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score


Information By: Columbia University

Dates:
Date Received: June 5, 2013
Date Started: November 2011
Date Completion:
Last Updated: October 13, 2016
Last Verified: October 2016