At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double Blind Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in ME/CFS
In Brief
A clinical study evaluating Placebo and Medical Food - Anhydrous Enol-Oxaloacetate for Myalgic Encephalomyelitis and 2 related conditions. Completed, enrolled 82 participants across 1 site.
Detailed Summary
There is no approved treatment for fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition with as many as 2.5 million people in the US. Initial case studies have shown an improvement in fatigue in ME/CFS with anhydrous enol-oxaloacetate (AEO). This randomized, double blinded, placebo controlled trial will seek to further evaluate the efficacy of AEO to reduce fatigue in ME/CFS, based on change in the Chalder Fatigue Score (Likert Scoring) of the AEO group against the placebo group at 90 days. As secondary evaluations on other core ME/CFS symptoms, the investigators are measuring the health related quality of life as assessed by the SF-36, hours of upright activity, functional capacity (activity, steps, cognition, and heart rate variability), and general health status (global change, vitals) Finally, this test will gain preliminary insights on the safety, tolerability, and efficacy of AEO in ME/CFS patients.
Study Details
Timeline
Interventions
Placebo treatment with the food white rice flour. 1,000 mg BID
Active treatment with oxaloacetate. 1,000 mg BID