Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

Chronic Fatigue Syndrome Clinical Trial

Official title:

Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01872351
• Other study ID #: AAAI1410
• Status: Withdrawn
• Phase: Phase 1
• First received: June 5, 2013
• Last updated: October 13, 2016
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Mitochondrial Diseases
• Syndrome

Intervention

Drug:
• Nutraceuticals

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance Questionnaire score		First 6 months vs. last 6 months of therapy	No
Primary	Modified Fatigue Severity Score (FSS-11)		6-40 months	No
Secondary	Other Symptoms Questionnaire score	Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score	6-40 months	No