The Role of Ribose in Patients Diagnosed With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Role of D-RIbose in Patients Diagnosed With Fibromyalgia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00566514
• Other study ID #: 200604-7
• Status: Suspended
• Phase: N/A
• First received: November 29, 2007
• Last updated: March 10, 2008
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: March 2008
• Source: Bioenergy Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• D-ribose
5 grams administered orally TID

Other:
• dextrose
5 grams orally TID

Locations

Country	Name	City	State
United States	Bioenergy Life Science, Inc.	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bioenergy Life Science, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant reduction in symptoms of pain and fatigue		3 weeks	No
Secondary	Demonstrate an improvement in ones quality of life		3 weeks	No