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Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

NCT01471652 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-13

No results posted yet for this study

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

Interventions

DRUG

Nutraceutical supplements

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Alfred E Slonim, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471652 on ClinicalTrials.gov