Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfred E. Slonim, Columbia University
ClinicalTrials.gov Identifier:
NCT01872351
First received: June 5, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

The purpose of this study was to determine whether therapy that has been shown to be beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS) patients. Patients received daily conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed nutraceutical supplements are alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: Nutraceuticals
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Benefit of Conditioning Exercise, High Protein Diet and Nutraceutical Supplements in Chronic Fatigue Syndrome: a Presumptive Mitochondrial Disorder

Resource links provided by NLM:


Further study details as provided by Columbia University:

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

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

Enrollment: 10
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 are 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 have received this therapy for varying lengths of time, ranging from 12 to 40 months.

  Eligibility

Ages Eligible for Study:   16 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
Alfred E. Slonim
Investigators
Principal Investigator: Alfred Slonim, MD Columbia University
  More Information

No publications provided

Responsible Party: Alfred E. Slonim, Professor of Clinical Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01872351     History of Changes
Other Study ID Numbers: AAAI1410
Study First Received: June 5, 2013
Last Updated: June 6, 2013
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
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Metabolic Diseases
Acetylcarnitine
Thioctic Acid
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014