Study Results
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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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2011-05-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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D-Ribose
D-Ribose Powder
5 g TID for 12 Weeks
Placebo
Placebo Powder
5 g TID for 12 Weeks
Interventions
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D-Ribose Powder
5 g TID for 12 Weeks
Placebo Powder
5 g TID for 12 Weeks
Eligibility Criteria
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Inclusion Criteria
* must have a score of ≥5 on the Subject's Assessment of Fatigue 11-point numerical rating scale (NRS) at the Pretreatment Screening and Baseline Visits;
* if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit;
* must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the Pretreatment Baseline Visit.
Exclusion Criteria
* has been diagnosed with any autoimmune disease;
* has been diagnosed with type I or type II diabetes;
* has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the Pretreatment Screening Visit;
* has been diagnosed with chronic fatigue syndrome.
18 Years
70 Years
ALL
No
Sponsors
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RiboCor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Leslie Crofford, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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Superior Research, LLC
Sacramento, California, United States
Avail Clinical Research
DeLand, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Columbia Medical Practice
Columbia, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Peters Medical Research
High Point, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Countries
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Other Identifiers
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BIOE 02C 010
Identifier Type: -
Identifier Source: org_study_id