The Role of Ribose in Patients Diagnosed With Fibromyalgia | NCT00566514

Studies
The Role of Ribose in Patients Diagnosed With Fibromyalgia

NCT00566514

Sponsor

Bioenergy Life Science, Inc.

Status

Suspended

Last Update Posted

Mar 13, 2008Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

D-ribose
dextrose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol Under Review

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jul 2008Estimated

Completion Date

Jul 2008Estimated

First Submitted Date

Nov 29, 2007

First Submission Date that Met QC Criteria

Nov 29, 2007

First Posted Date

Dec 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2008

Last Update Posted Date

Mar 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	D-ribose 5 grams TID orally	Dietary Supplement: D-ribose
2	Placebo Comparator	Dextrose 5 grams TID	Other: dextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D-ribose	Dietary Supplement	5 grams administered orally TID	1	Corvalen

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bioenergy Life Science, Inc.		Minneapolis	Minnesota	55304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17109576	Background	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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

ID	Term
D012266	Ribose
D005947	Glucose

ID	Term
D010429	Pentoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D006601