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

This study has been completed.
Sponsor:
Collaborators:
Bioenergy Life Science, Inc.
Integrative Therapeutics, Inc.
Information provided by:
Kona Research Center
ClinicalTrials.gov Identifier:
NCT01108549
First received: April 16, 2010
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention
Fibromyalgia
Chronic Fatigue Syndrome
 Dietary Supplement: Ribose

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kona Research Center:

Primary Outcome Measures:
  • total score of hedonic scale of 5 symptoms [ Time Frame: Change in total score of 5 symptoms after 3 weeks of treatment ] [ Designated as safety issue: No ]
    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:
  • Total of change in hedonic scale [ Time Frame: at 1 week of treatment ] [ Designated as safety issue: No ]
    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

  • total change in hedonic scale [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Side effects [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    subjects and health practitioners were asked to report any side effects


Enrollment: 257
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Ribose
    Ribose 5 grams PO TID was taken daily
    Other Name: D-ribose, corvalen
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108549

Locations
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
Principal Investigator: Jacob E Teitelbaum, MD Kona Research Center
  More Information

No publications provided

Responsible Party: Jacob Teitelbaum MD, Kona Research Center
ClinicalTrials.gov Identifier: NCT01108549     History of Changes
Other Study ID Numbers: RiboseCFS03
Study First Received: April 16, 2010
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kona Research Center:
Fibromyalgia
Chronic Fatigue Syndrome
D-ribose
fatigue

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Signs and Symptoms
Virus Diseases
Muscular Diseases
 Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013