To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of fibromyalgia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
5 g TID for 12 Weeks
5 g TID for 12 Weeks
Superior Research, LLC
Sacramento, California, United States
Avail Clinical Research
DeLand, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
University of Kentucky
Subject's Assessment of Fatigue (NRS)
Time frame: 12 Weeks
Revised Fibromyalgia Impact Questionnaire
Time frame: 12 Weeks
Multidimensional Fatigue Inventory
Time frame: 12 Weeks
Subject's Global Impression of Change
Time frame: 12 Weeks
SF-36
Time frame: 12 Weeks
Subject's Assessment of Pain Intensity (NRS)
Time frame: 12 Weeks
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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