FibromyalgiaNCT01108549
Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
A study testing Ribose in people with Fibromyalgia and Chronic Fatigue Syndrome, run by Kona Research Center at 1 site in United States.
Trial summary
To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome
- What is being tested?
- Ribose
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology [ACR] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control [CDC] criteria) by a health practitioner.
Who cannot join
- pregnant or nursing women, or
- any participants with known severe medication or nutrient sensitivities, or
- previous ribose use.
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).
Read the detailed description
Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting ~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.
As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Being tested
- Ribose
- Keywords
- Fibromyalgia, Chronic Fatigue Syndrome, D-ribose, fatigue
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboseDietary supplement
Also called D-ribose, corvalen
Ribose 5 grams PO TID was taken daily
What is being measured
The primary outcome is the main question the study is designed to answer.
total score of hedonic scale of 5 symptoms
The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale
Measured: Change in total score of 5 symptoms after 3 weeks of treatment
Secondary outcomes (3)
Total of change in hedonic scale
The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale
Measured: at 1 week of treatment
total change in hedonic scale
The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale
Measured: after 2 weeks of treatment
Side effects
subjects and health practitioners were asked to report any side effects
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 posted22 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kona Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bioenergy Life Science, Inc., Integrative Therapeutics, Inc.
- Investigators
- Jacob E Teitelbaum, MD, Principal investigator, Kona Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108549
- Sponsor's protocol ID
- RiboseCFS03
- Status last verified
- Apr 2010
- First submitted
- 16 Apr 2010
- Last updated
- 22 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study
- ClinicalTrials.gov ID
- NCT01108549
- Acronym / sponsor ID
- RiboseCFS03
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Keywords
- Fibromyalgia, Chronic Fatigue Syndrome, D-ribose, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Kona Research CenterUniversity, hospital or other
- Collaborators
- Bioenergy Life Science, Inc., Integrative Therapeutics, Inc.
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Apr 2010 (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.
To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).
Detailed description
Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) are debilitating syndromes affecting ~ 2-4% of the population. Although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism.
As D-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in CFS/FMS in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. We hypothesized that giving D-ribose would improve function in CFS/FMS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology [ACR] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control [CDC] criteria) by a health practitioner.
Key exclusion criteria (3 listed)
- pregnant or nursing women, or
- any participants with known severe medication or nutrient sensitivities, or
- previous ribose use.
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 |
|---|---|---|
| RiboseAlso: D-ribose, corvalenRibose 5 grams PO TID was taken daily | Dietary supplement | – |
Primary outcome
total score of hedonic scale of 5 symptoms
Time frame: Change in total score of 5 symptoms after 3 weeks of treatment
The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale
3 secondary outcomes
Total of change in hedonic scale
Time frame: at 1 week of treatment
total change in hedonic scale
Time frame: after 2 weeks of treatment
Side effects
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2010.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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 E Teitelbaum, MD principal investigator
Kona Research 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 Ribose in people with Fibromyalgia and Chronic Fatigue Syndrome, run by Kona Research Center 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 Apr 2010. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
total score of hedonic scale of 5 symptoms (time frame: Change in total score of 5 symptoms after 3 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2010.