FibromyalgiaNCT00566514
The Role of Ribose in Patients Diagnosed With Fibromyalgia
A study testing D-ribose and dextrose in people with Fibromyalgia, run by Bioenergy Life Science, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- D-ribose and dextrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioenergy Life Science, Inc.
Minneapolis, Minnesota, 55304
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- D-ribose, dextrose
- Keywords
- fibromyalgia, ribose, d-ribose, dextrose
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-riboseDietary supplement
Also called Corvalen
5 grams administered orally TID
dextroseOther
5 grams orally TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | D-ribose 5 grams TID orally Receives: Dietary Supplement: D-ribose |
| 2 | Placebo comparator | Dextrose 5 grams TID Receives: Other: dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in symptoms of pain and fatigue
Measured: 3 weeks
Secondary outcomes (1)
Demonstrate an improvement in ones quality of life
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startJul 2006
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Why it stopped: Protocol Under Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioenergy Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacob Teitelbaum, MD, Principal investigator, The Annapolis Center for Effective CFS/Fibromyalgia TherapiesKent Holtorf, MD, Principal investigator, Hormone and Longevity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566514
- Sponsor's protocol ID
- 200604-7
- Status last verified
- Mar 2008
- First submitted
- 29 Nov 2007
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17109576
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of D-RIbose in Patients Diagnosed With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00566514
- Acronym / sponsor ID
- 200604-7
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, ribose, d-ribose, dextrose
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol Under Review
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bioenergy Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 3 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: D-riboseD-ribose 5 grams TID orally |
| 2 | Placebo comparator | Other: dextroseDextrose 5 grams TID |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-riboseAlso: Corvalen5 grams administered orally TID | Dietary supplement | 1 |
| dextrose5 grams orally TID | Other | 2 |
Primary outcome
Significant reduction in symptoms of pain and fatigue
Time frame: 3 weeks
1 secondary outcome
Demonstrate an improvement in ones quality of life
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Background: PubMed 17109576Teitelbaum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Teitelbaum, MD principal investigator
The Annapolis Center for Effective CFS/Fibromyalgia Therapies
Kent Holtorf, MD principal investigator
Hormone and Longevity Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-ribose and dextrose in people with Fibromyalgia, run by Bioenergy Life Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant reduction in symptoms of pain and fatigue (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00566514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2008.