Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

NCT ID: NCT01872351

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-11-30

Brief 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.

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Nutraceuticals

Intervention Type: DRUG

Interventions

Nutraceuticals

Intervention Type: DRUG

Other Intervention 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

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred Slonim, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAI1410

Identifier Type: -

Identifier Source: org_study_id