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Completed

NCT Number: NCT01108549

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

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).

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Key information

Conditions

Fibromyalgia Chronic Disease Chronic Fatigue Syndrome Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enzymatic Therapy

Green Bay, Wisconsin, 54311, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribose

Dietary Supplement

Ribose 5 grams PO TID was taken daily

Other names: D-ribose, corvalen

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kona Research Center

Other

Collaborators

  • Bioenergy Life Science, Inc.
  • Integrative Therapeutics, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2010
Registry last updated
Apr 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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