Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors
NCT04592354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-10-19
Summary
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment.
Participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Conditions
- Treatment of Fatigue After Resolution of COVID-19 Infection
Interventions
- DIETARY_SUPPLEMENT
-
Oxaloacetate Medical Food/Dietary Supplement
500 mg Anhydrous Enol-Oxaloacetate BID
Sponsors & Collaborators
-
Terra Biological LLC
lead INDUSTRY
Principal Investigators
-
Lisa Tully, Ph.D. · Energy Medicine Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-15
- Primary Completion
- 2021-04-15
- Completion
- 2021-06-15
Countries
- United States
Study Locations
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