Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder

NCT01872351 | Withdrawn DMC

• 1 other identifier: AAAI1410
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

chronic fatigue syndrome; mitochondrial disorder; conditioning exercise; nutraceutical supplements; high protein diet

Outcome Measures

Primary Outcomes (1)

• Modified Fatigue Severity Score (FSS-11)

  6-40 months

Secondary Outcomes (1)

• Other Symptoms Questionnaire score

  6-40 months

Other Outcomes (1)

• Compliance Questionnaire score

  First 6 months vs. last 6 months of therapy

Study Arms (1)

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

Interventions

Nutraceuticals DRUG

Also known as: 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

pre and 12 months post ENT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Additional medical illnesses causing chronic fatigue
• Ongoing exertion

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Mitochondrial Diseases

Interventions

Dietary Supplements; Acetylcarnitine; BID protein, human; Thioctic Acid; coenzyme Q10; Geritol

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; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Alfred Slonim, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)