Clinical trial NCT01872351: Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder
Official title: Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Fatigue Syndrome
Keywords: chronic fatigue syndrome
mitochondrial disorder
conditioning exercise
nutraceutical supplements
high protein diet
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. Subjects will be screened for eligibility; the study will be explained and a verbal consent will be given over the telephone. If the subject agrees, they will be sent a questionnaire assessing their clinical and fatigue status prior to starting ENT and their present clinical and fatigue status, as well as their compliance to ENT.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Fatigue Severity Score (FSS-11)
timeFrame: 6-40 months
Secondary outcomes:
measure: Other Symptoms Questionnaire score
timeFrame: 6-40 months
Other outcomes:
measure: Compliance Questionnaire score
timeFrame: First 6 months vs. last 6 months of therapy
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Alfred Slonim, MD
role: PRINCIPAL_INVESTIGATOR
References: