The Role of Ribose in Patients Diagnosed With Fibromyalgia

NCT ID: NCT00566514

Last Updated: 2008-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

D-ribose 5 grams TID orally

Group Type ACTIVE_COMPARATOR

D-ribose

Intervention Type DIETARY_SUPPLEMENT

5 grams administered orally TID

2

Dextrose 5 grams TID

Group Type PLACEBO_COMPARATOR

dextrose

Intervention Type OTHER

5 grams orally TID

Interventions

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D-ribose

5 grams administered orally TID

Intervention Type DIETARY_SUPPLEMENT

dextrose

5 grams orally TID

Intervention Type OTHER

Other Intervention Names

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Corvalen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioenergy Life Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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The Annapolis Center for Effective CFS/Fibromyalgia Therapies

Principal Investigators

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Jacob Teitelbaum, MD

Role: PRINCIPAL_INVESTIGATOR

The Annapolis Center for Effective CFS/Fibromyalgia Therapies

Kent Holtorf, MD

Role: PRINCIPAL_INVESTIGATOR

Hormone and Longevity Medical Center

Locations

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Bioenergy Life Science, Inc.

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17109576 (View on PubMed)

Other Identifiers

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200604-7

Identifier Type: -

Identifier Source: org_study_id

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