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
  Purpose

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 Intervention
Fibromyalgia
Dietary Supplement: D-ribose
Other: dextrose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of D-RIbose in Patients Diagnosed With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Bioenergy Life Science, Inc.:

Primary Outcome Measures:
  • Significant reduction in symptoms of pain and fatigue [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate an improvement in ones quality of life [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2006
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566514

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

Publications:
Responsible Party: Jacob Teitelbaum, MD, The Annapolis Center for Effective CFS/Fibromyalgia Therapies
ClinicalTrials.gov Identifier: NCT00566514     History of Changes
Other Study ID Numbers: 200604-7
Study First Received: November 29, 2007
Last Updated: March 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Bioenergy Life Science, Inc.:
fibromyalgia
ribose
d-ribose
dextrose

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

ClinicalTrials.gov processed this record on April 17, 2014