Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder
|ClinicalTrials.gov Identifier: NCT01872351|
Recruitment Status : Withdrawn (PI left the institution)
First Posted : June 7, 2013
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome||Drug: Nutraceuticals||Phase 1|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder|
|Study Start Date :||November 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
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
- Modified Fatigue Severity Score (FSS-11) [ Time Frame: 6-40 months ]
- Other Symptoms Questionnaire score [ Time Frame: 6-40 months ]Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score
- Compliance Questionnaire score [ Time Frame: First 6 months vs. last 6 months of therapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872351
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Alfred Slonim, MD||Columbia University|