Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

This study has been withdrawn prior to enrollment.
(PI left the institution)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01872351
First received: June 5, 2013
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: Nutraceuticals
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Modified Fatigue Severity Score (FSS-11) [ Time Frame: 6-40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other Symptoms Questionnaire score [ Time Frame: 6-40 months ] [ Designated as safety issue: No ]
    Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score


Other Outcome Measures:
  • Compliance Questionnaire score [ Time Frame: First 6 months vs. last 6 months of therapy ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pre and 12 months post ENT

Compare the clinical status of CFS patients after at least 12 months of ENT to their status before ENT.

ENT consists of:

Daily conditioning exercise: 35-40 minutes

Nutraceutical supplements: acetyl-L-carnitine 500 mg bid, alpha-lipoic acid (Alpha Lipoic Sustain 300) 300 mg qd, CoQ10 (Ubiquinol QH-absorb) 100 mg qd, docosahexanoic acid (maxDHA) 300 mg qd, plus a multivitamin (Centrum Silver) ½ tab bid.

Diet: 25% protein, 35- 40% carbohydrate, 35-40% fat

Drug: Nutraceuticals
Other Names:
  • Jarrow Formulas:
  • - acetyl-L-carnitine 500 mg bid
  • - alpha-lipoic acid (Alpha Lipoic Sustain 300) 300 mg qd
  • - CoQ10 (Ubiquinol QH-absorb) 100 mg qd
  • - docosahexanoic acid (maxDHA) 300 mg qd
  • Pfizer Consumer Healthcare:
  • - multivitamin (Centrum Silver) ½ tab bid

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872351

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Alfred Slonim, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01872351     History of Changes
Other Study ID Numbers: AAAI1410
Study First Received: June 5, 2013
Last Updated: April 9, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
chronic fatigue syndrome
mitochondrial disorder
conditioning exercise
nutraceutical supplements
high protein diet

Additional relevant MeSH terms:
Mitochondrial Diseases
Fatigue
Fatigue Syndrome, Chronic
Syndrome
Central Nervous System Diseases
Disease
Encephalomyelitis
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Signs and Symptoms
Virus Diseases
Acetylcarnitine
Thioctic Acid
Antioxidants
Central Nervous System Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on May 21, 2015