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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014