The Role of Ribose in Patients Diagnosed With Fibromyalgia

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. Identifier: NCT00566514
Recruitment Status : Suspended (Protocol Under Review)
First Posted : December 3, 2007
Last Update Posted : March 13, 2008
Information provided by:
Bioenergy Life Science, Inc.

Brief Summary:
The purose of this research study is to determine the potential benefit of D-ribose, a nutritional supplement (a sugar), versus a placebo (another sugar) in people with fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: D-ribose Other: dextrose Not Applicable

Detailed Description:
Two hundred to three hundred subjects (equally distribued between placebo and D-ribose) between 18-78 years of age will comprise this study. The final numbers enrolled will depend upon obtaining approximately 100 subjects that can display a high degree of compliance to TID dosing with approximately equal balance between the active and placebo arms.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of D-RIbose in Patients Diagnosed With Fibromyalgia
Study Start Date : July 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
D-ribose 5 grams TID orally
Dietary Supplement: D-ribose
5 grams administered orally TID
Other Name: Corvalen
Placebo Comparator: 2
Dextrose 5 grams TID
Other: dextrose
5 grams orally TID

Primary Outcome Measures :
  1. Significant reduction in symptoms of pain and fatigue [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Demonstrate an improvement in ones quality of life [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • previous diagnosis of fibromomyalgia by a MD
  • Has been diagnosed with fibromyalgia and are over 18 years of age
  • Does live in the United States

Exclusion Criteria:

  • does NOT have severe medication/chemical/supplement sensitivities
  • does NOT have insulin dependent diabetes or other severe illnesses (cancer, hepatitis, congestive heart failure)
  • does NOT have rheumatoid arthritis or gout
  • previous use of ribose

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 identifier (NCT number): NCT00566514

United States, Minnesota
Bioenergy Life Science, Inc.
Minneapolis, Minnesota, United States, 55304
Sponsors and Collaborators
Bioenergy Life Science, Inc.
Principal Investigator: Jacob Teitelbaum, MD The Annapolis Center for Effective CFS/Fibromyalgia Therapies
Principal Investigator: Kent Holtorf, MD Hormone and Longevity Medical Center

Responsible Party: Jacob Teitelbaum, MD, The Annapolis Center for Effective CFS/Fibromyalgia Therapies Identifier: NCT00566514     History of Changes
Other Study ID Numbers: 200604-7
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by Bioenergy Life Science, Inc.:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases