Chronic Fatigue SyndromeNCT01872351
Therapy for Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder
An observational study of Chronic Fatigue Syndrome, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Nutraceuticals
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Additional medical illnesses causing chronic fatigue
- Ongoing exertion
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder
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.
Read the 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
- Being tested
- Nutraceuticals
- Keywords
- chronic fatigue syndrome, mitochondrial disorder, conditioning exercise, nutraceutical supplements, high protein diet
- Medical subject headings
- Fatigue Syndrome, Chronic, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraceuticalsDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nutraceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Severity Score (FSS-11)
Measured: 6-40 months
Secondary outcomes (1)
Other Symptoms Questionnaire score
Assess pre/post symptoms of CFS not covered by the Modified Fatigue Severity Score
Measured: 6-40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred Slonim, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872351
- Sponsor's protocol ID
- AAAI1410
- Status last verified
- Oct 2016
- First submitted
- 5 Jun 2013
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Chronic Fatigue Syndrome as a Mitochondrial Disorder
- ClinicalTrials.gov ID
- NCT01872351
- Acronym / sponsor ID
- AAAI1410
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- chronic fatigue syndrome, mitochondrial disorder, conditioning exercise, nutraceutical supplements, high protein diet
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre and 12 months post ENT | – | Drug: NutraceuticalsCompare 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Additional medical illnesses causing chronic fatigue
- Ongoing exertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutraceuticalsAlso: 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 | Drug | pre and 12 months post ENT |
Primary outcome
Modified Fatigue Severity Score (FSS-11)
Time frame: 6-40 months
1 secondary outcome
Other Symptoms Questionnaire score
Time frame: 6-40 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Slonim, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Severity Score (FSS-11) (time frame: 6-40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.