Skip to content

Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01872351
Enrollment
0
Registered
2013-06-07
Start date
2011-11-30
Completion date
2012-11-30
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Keywords

chronic fatigue syndrome, mitochondrial disorder, conditioning exercise, nutraceutical supplements, high protein diet

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 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.

Interventions

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Exclusion criteria

* Additional medical illnesses causing chronic fatigue * Ongoing exertion

Design outcomes

Primary

MeasureTime frame
Modified Fatigue Severity Score (FSS-11)6-40 months

Secondary

MeasureTime frameDescription
Other Symptoms Questionnaire score6-40 monthsAssess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score

Other

MeasureTime frame
Compliance Questionnaire scoreFirst 6 months vs. last 6 months of therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026