NCT00566514

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

Enrollment Period

2 years

First QC Date

November 29, 2007

Last Update Submit

March 10, 2008

Conditions

Keywords

fibromyalgiaribosed-ribosedextrose

Outcome Measures

Primary Outcomes (1)

  • Significant reduction in symptoms of pain and fatigue

    3 weeks

Secondary Outcomes (1)

  • Demonstrate an improvement in ones quality of life

    3 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

D-ribose 5 grams TID orally

Dietary Supplement: D-ribose

2

PLACEBO COMPARATOR

Dextrose 5 grams TID

Other: dextrose

Interventions

D-riboseDIETARY_SUPPLEMENT

5 grams administered orally TID

Also known as: Corvalen
1

5 grams orally TID

2

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioenergy Life Science, Inc.

Minneapolis, Minnesota, 55304, United States

Location

Related Publications (1)

  • 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.

    PMID: 17109576BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

RiboseGlucose

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PentosesMonosaccharidesSugarsCarbohydratesHexoses

Study Officials

  • Jacob Teitelbaum, MD

    The Annapolis Center for Effective CFS/Fibromyalgia Therapies

    PRINCIPAL INVESTIGATOR
  • Kent Holtorf, MD

    Hormone and Longevity Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

July 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 13, 2008

Record last verified: 2008-03

Locations