The Role of Ribose in Patients Diagnosed With Fibromyalgia

• Sponsor: Bioenergy Life Science, Inc. (Industry)
• Overall Status: Suspended
• CT.gov ID: NCT00566514
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2006
• Anticipated Primary Completion Date: Jul 1, 2008
• Anticipated Study Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Significant reduction in symptoms of pain and fatigue [3 weeks]

Secondary Outcome Measures

1. Demonstrate an improvement in ones quality of life [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00566514
• Other Study ID Numbers: 200604-7
• First Posted: Dec 3, 2007
• Last Update Posted: Mar 13, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: fibromyalgia; ribose; d-ribose; dextrose
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes

Study Results

No Results Posted as of Mar 13, 2008