The Role of Ribose in Patients Diagnosed With Fibromyalgia

March 10, 2008 updated by: Bioenergy Life Science, Inc.

The Role of D-RIbose in Patients Diagnosed With Fibromyalgia

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

200

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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55304
        • Bioenergy Life Science, Inc.

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 to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
D-ribose 5 grams TID orally
Dietary supplement: D-ribose
5 grams administered orally TID
Other Names:
  • Corvalen
Placebo Comparator: 2
Dextrose 5 grams TID
Other: dextrose
5 grams orally TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant reduction in symptoms of pain and fatigue
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstrate an improvement in ones quality of life
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

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

Sponsor

Bioenergy Life Science, Inc.

Investigators

  • Principal Investigator: Jacob Teitelbaum, MD, The Annapolis Center for Effective CFS/Fibromyalgia Therapies
  • Principal Investigator: Kent Holtorf, MD, Hormone and Longevity Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2006

Primary Completion (Anticipated)

July 1, 2008

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

March 13, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200604-7

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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