Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

NCT01471652 | Withdrawn Phase 2 DMC

• 1 other identifier: AAAJ0702
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective therapy has been developed. Recent studies suggest that a preceding viral infection causes mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible individuals. There is no specific laboratory test to identify patients with CFS. However, certain clinical manifestations are similar to those seen in mitochondrial disorders. Both patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain glutathione levels on nuclear magnetic resonance (NMR) spectroscopy. Therapy consisting of daily conditioning exercise, dietary recommendations, and nutraceutical supplements (ENT) has been show to be beneficial in treating patients with mitochondrial disorders. Similar therapy has been instituted in individual patients with CFS and has been shown to also improve their clinical conditions. A placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical causes for fatigue will be excluded. Half the patients will receive treatment consisting of daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be beneficial for patients with mitochondrial dysfunction, while the other half will receive daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by maximum oxygen consumption (VO2max) and circulating lactate levels during \& after treadmill exercise, a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT corrects the elevated brain cerebrospinal fluid levels and decreased brain glutathione levels will be measured. To ensure compliance to therapy patients will be monitored frequently. The objective of this study is to assess the safety and efficacy of ENT and whether ENT leads to sustained improvement of CFS patients compared to their baseline status, and compared to an exercised group of patients not receiving supplements.

Conditions

Chronic Fatigue Syndrome

Keywords

myalgic encephalopathy; chronic fatigue syndrome; post viral infection; fatigue; muscle pain; unrefreshing sleep; fuzzy thought; poor memory; forgetfulness

Outcome Measures

Primary Outcomes (1)

• Change in rate of fatigue status and other CFS symptoms

  Rate of decrease in fatigue and other CFS symptoms, as measured by SF-36 and The Fatigue Assessment Instrument.

  0, 3, and 6 months

Secondary Outcomes (1)

• Change in brain lactate and glutathione levels

  0 and 6 months

Study Arms (2)

Nutraceuticals

ACTIVE COMPARATOR

Subjects will receive a combination of 4 nutraceuticals (CoEnzyme Q10, acetyl-L-carnitine, alpha-lipoic acid, docosahexaenoic acid (DHA)) and a multivitamin.

Drug: Nutraceutical supplements

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nutraceutical supplements DRUG

1. CoEnzyme Q10: oral gel capsule bid 2. Acetyl L-carnitine: oral capsule bid 3. Alpha Lipoic Acid: oral tablet qd 4. Docosahexaenoic acid: oral gel capsule bid

Nutraceuticals

Placebo DRUG

Capsule form to imitate the following nutraceuticals: 1. Placebo 1: oral gel capsule bid 2. Placebo 2: oral capsule bid 3. Placebo 3: oral tablet qd 4. Placebo 4: oral gel capsule bid

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the criteria for CFS of the US Centers for Disease Control and Prevention (CDC), which requires 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
• post-exertional malaise
• As well, due to the frequency of visits subjects must currently reside in the greater New York area.

You may not qualify if:

• shortness of breath
• heart disease
• high blood pressure
• other severe chronic illnesses
• clinical depression
• generalized anxiety disorder
• insomnia
• inflammatory arthritis
• anemia
• hypothyroidism
• other conditions associated with significant fatigue
• history of alcohol, tobacco, or drug abuse

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Department of Clinical Genetics

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue; Myalgia; Memory Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Pain; Neurologic Manifestations; Neurobehavioral Manifestations

Study Officials

• Alfred E Slonim, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 15, 2011
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

US (1)