The Role of Ribose in Patients Diagnosed With Fibromyalgia

This study has suspended participant recruitment.
(Protocol Under Review)
Sponsor:
Information provided by:
Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT00566514
First received: November 29, 2007
Last updated: March 10, 2008
Last verified: March 2008

November 29, 2007
March 10, 2008
July 2006
July 2008   (final data collection date for primary outcome measure)
Significant reduction in symptoms of pain and fatigue [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00566514 on ClinicalTrials.gov Archive Site
Demonstrate an improvement in ones quality of life [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Role of Ribose in Patients Diagnosed With Fibromyalgia
The Role of D-RIbose in Patients Diagnosed With Fibromyalgia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Fibromyalgia
  • Dietary Supplement: D-ribose
    5 grams administered orally TID
    Other Name: Corvalen
  • Other: dextrose
    5 grams orally TID
  • Active Comparator: 1
    D-ribose 5 grams TID orally
    Intervention: Dietary Supplement: D-ribose
  • Placebo Comparator: 2
    Dextrose 5 grams TID
    Intervention: Other: dextrose
Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
200
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566514
200604-7
No
Jacob Teitelbaum, MD, The Annapolis Center for Effective CFS/Fibromyalgia Therapies
Bioenergy Life Science, Inc.
Not Provided
Principal Investigator: Jacob Teitelbaum, MD The Annapolis Center for Effective CFS/Fibromyalgia Therapies
Principal Investigator: Kent Holtorf, MD Hormone and Longevity Medical Center
Bioenergy Life Science, Inc.
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP