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

Primary Purpose

Fibromyalgia, Chronic Fatigue Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ribose
Sponsored by
Kona Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Chronic Fatigue Syndrome, D-ribose, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Enzymatic Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Side effects
subjects and health practitioners were asked to report any side effects

Full Information

First Posted
April 16, 2010
Last Updated
April 20, 2010
Sponsor
Kona Research Center
Collaborators
Bioenergy Life Science, Inc., Integrative Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01108549
Brief Title
Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
Official Title
Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kona Research Center
Collaborators
Bioenergy Life Science, Inc., Integrative Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Fatigue Syndrome
Keywords
Fibromyalgia, Chronic Fatigue Syndrome, D-ribose, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Ribose
Other Intervention Name(s)
D-ribose, corvalen
Intervention Description
Ribose 5 grams PO TID was taken daily
Primary Outcome Measure Information:
Title
total score of hedonic scale of 5 symptoms
Description
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
Time Frame
Change in total score of 5 symptoms after 3 weeks of treatment
Secondary Outcome Measure Information:
Title
Total of change in hedonic scale
Description
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
Time Frame
at 1 week of treatment
Title
total change in hedonic scale
Description
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
Time Frame
after 2 weeks of treatment
Title
Side effects
Description
subjects and health practitioners were asked to report any side effects
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob E Teitelbaum, MD
Organizational Affiliation
Kona Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enzymatic Therapy
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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