search
Back to results

The Role of Ribose in Patients Diagnosed With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D-ribose
dextrose
Sponsored by
Bioenergy Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring fibromyalgia, ribose, d-ribose, dextrose

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bioenergy Life Science, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

D-ribose 5 grams TID orally

Dextrose 5 grams TID

Outcomes

Primary Outcome Measures

Significant reduction in symptoms of pain and fatigue

Secondary Outcome Measures

Demonstrate an improvement in ones quality of life

Full Information

First Posted
November 29, 2007
Last Updated
March 10, 2008
Sponsor
Bioenergy Life Science, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00566514
Brief Title
The Role of Ribose in Patients Diagnosed With Fibromyalgia
Official Title
The Role of D-RIbose in Patients Diagnosed With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Suspended
Why Stopped
Protocol Under Review
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bioenergy Life Science, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, ribose, d-ribose, dextrose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
D-ribose 5 grams TID orally
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Dextrose 5 grams TID
Intervention Type
Dietary Supplement
Intervention Name(s)
D-ribose
Other Intervention Name(s)
Corvalen
Intervention Description
5 grams administered orally TID
Intervention Type
Other
Intervention Name(s)
dextrose
Intervention Description
5 grams orally TID
Primary Outcome Measure Information:
Title
Significant reduction in symptoms of pain and fatigue
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Demonstrate an improvement in ones quality of life
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Teitelbaum, MD
Organizational Affiliation
The Annapolis Center for Effective CFS/Fibromyalgia Therapies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kent Holtorf, MD
Organizational Affiliation
Hormone and Longevity Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bioenergy Life Science, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17109576
Citation
Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62. doi: 10.1089/acm.2006.12.857.
Results Reference
background

Learn more about this trial

The Role of Ribose in Patients Diagnosed With Fibromyalgia

We'll reach out to this number within 24 hrs