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

Not Applicable

Completed

• Conditions: Fibromyalgia; Chronic Fatigue Syndrome

• Registration Number: NCT01108549
• Lead Sponsor: Kona Research Center

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-04
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-20
• Last Update Submitted: 2010-04-20
• Study First Posted: 2010-04-22
• Last Update Posted: 2010-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
total score of hedonic scale of 5 symptoms	Change in total score of 5 symptoms after 3 weeks of treatment	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

Secondary Outcome Measures

Name	Time	Method
Total of change in hedonic scale	at 1 week of treatment	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
total change in hedonic scale	after 2 weeks of treatment	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
Side effects	3 weeks	subjects and health practitioners were asked to report any side effects

Trial Locations

Locations (1)

Enzymatic Therapy; 🇺🇸 Green Bay, Wisconsin, United States