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Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01108549
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : April 22, 2010
Sponsor:
Collaborators:
Bioenergy Life Science, Inc.
Integrative Therapeutics, Inc.
Information provided by:
Kona Research Center

Study Description
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Brief Summary:
To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Fatigue Syndrome Dietary Supplement: Ribose Not Applicable

Detailed Description:

Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting ~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.

As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
Study Start Date : April 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Ribose
    Ribose 5 grams PO TID was taken daily
    Other Name: D-ribose, corvalen

Outcome Measures
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Primary Outcome Measures :
  1. total score of hedonic scale of 5 symptoms [ Time Frame: Change in total score of 5 symptoms after 3 weeks of treatment ]
    The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale


Secondary Outcome Measures :
  1. Total of change in hedonic scale [ Time Frame: at 1 week of treatment ]
    The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale

  2. total change in hedonic scale [ Time Frame: after 2 weeks of treatment ]
    The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale

  3. Side effects [ Time Frame: 3 weeks ]
    subjects and health practitioners were asked to report any side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology [ACR] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control [CDC] criteria) by a health practitioner.

Exclusion Criteria:

  • pregnant or nursing women, or
  • any participants with known severe medication or nutrient sensitivities, or
  • previous ribose use.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108549


Locations
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United States, Wisconsin
Enzymatic Therapy
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
Kona Research Center
Bioenergy Life Science, Inc.
Integrative Therapeutics, Inc.
Investigators
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Principal Investigator: Jacob E Teitelbaum, MD Kona Research Center
More Information
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Responsible Party: Jacob Teitelbaum MD, Kona Research Center
ClinicalTrials.gov Identifier: NCT01108549    
Other Study ID Numbers: RiboseCFS03
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010
Keywords provided by Kona Research Center:
Fibromyalgia
Chronic Fatigue Syndrome
D-ribose
fatigue
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Fatigue
Disease
Pathologic Processes
Muscular Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Infections
Encephalomyelitis
Central Nervous System Diseases