Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study

Fibromyalgia Clinical Trial

Official title:

Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108549
• Other study ID #: RiboseCFS03
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: April 20, 2010
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: April 2010
• Source: Kona Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).

Description:

Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting ~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.

As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology [ACR] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control [CDC] criteria) by a health practitioner.

Exclusion Criteria:

• pregnant or nursing women, or

• any participants with known severe medication or nutrient sensitivities, or

• previous ribose use.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

Intervention

Dietary Supplement:
• Ribose
Ribose 5 grams PO TID was taken daily

Locations

Country	Name	City	State
United States	Enzymatic Therapy	Green Bay	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Kona Research Center	Bioenergy Life Science, Inc., Integrative Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total score of hedonic scale of 5 symptoms	The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale	Change in total score of 5 symptoms after 3 weeks of treatment	No
Secondary	Total of change in hedonic scale	The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale	at 1 week of treatment	No
Secondary	total change in hedonic scale	The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale	after 2 weeks of treatment	No
Secondary	Side effects	subjects and health practitioners were asked to report any side effects	3 weeks	Yes