Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

Sponsor

Columbia University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01872351

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Drug: Nutraceuticals

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Nutraceuticals Other Names: Jarrow Formulas: - 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 Pfizer Consumer Healthcare: - multivitamin (Centrum Silver) ½ tab bid

Arm

Intervention/Treatment

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

Drug: Nutraceuticals

Other Names:

Jarrow Formulas:

- 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

Pfizer Consumer Healthcare:

- multivitamin (Centrum Silver) ½ tab bid

Outcome Measures

Primary Outcome Measures

Modified Fatigue Severity Score (FSS-11) [6-40 months]

Secondary Outcome Measures

Other Symptoms Questionnaire score [6-40 months]
Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score

Other Outcome Measures

Compliance Questionnaire score [First 6 months vs. last 6 months of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.