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

April 20, 2010 updated by: Kona Research Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

257

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Enzymatic Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total score of hedonic scale of 5 symptoms
Time Frame: 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
Change in total score of 5 symptoms after 3 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kona Research Center

Collaborators

Integrative Therapeutics, Inc.
Bioenergy Life Science, Inc.

Investigators

  • Principal Investigator: Jacob E Teitelbaum, MD, Kona Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 22, 2010

Last Update Submitted That Met QC Criteria

April 20, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiboseCFS03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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