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NCT05618574 · ClinicalTrials.gov registry record · Phase 2
Nitrite Supplementation in Long COVID Patients
A Phase 2 study of Long COVID and Cardiorespiratory Fitness, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT05618574: Completed Phase 2 study of Long COVID and Cardiorespiratory Fitness, sponsored by VA Office of Research and Development.
NCT05618574 is a Phase 2 study of Long COVID and Cardiorespiratory Fitness that has completed, run by VA Office of Research and Development. The registered enrollment target is 17 participants, below the 2,188-participant average among 50 other Long COVID trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05618574, a Phase 2 study of Long COVID and Cardiorespiratory Fitness, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo beverage. Both groups will receive physical therapy at the long COVID Clinic at VAPHS with therapeutic goals to improve strength, balance, inspiratory, and aerobic capabilities. Physical therapy will last for 2 weeks and include 2 or 3 sessions with a physical therapist a week depending on each individual's exercise tolerance. These sessions can take place on-site or at home (or a hybrid combination) All participants will undergo functional assessments and tissue assessments before and after the 14-day study intervention.
Primary Outcome
Rating of Rate of Perceived Exertion (RPE) during the 5th minute of a 5-min of a 1.5 mile per hour steady-state treadmill walking test is used as an assessment of fatigability. RPE scale is from 6 (no physical exertion) - 20 (maximal exertion/very hard). This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK)
- DIETARY_SUPPLEMENT 210 ml of nitrate-depleted placebo
Study Locations (1)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 2 |
What the finished NCT05618574 record still lists
NCT05618574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,188-participant average among 50 other Long COVID trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Long COVID appearing as the primary indexed condition, and to 2 interventions - of which 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK) is the first listed.
NCT05618574 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05618574 about?
NCT05618574 is a clinical study titled "Nitrite Supplementation in Long COVID Patients". Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo b...
What is the current status of trial NCT05618574?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2023-12-01. Estimated completion is 2025-02-14.
What conditions does trial NCT05618574 study?
This clinical trial studies the following conditions: Long COVID, Cardiorespiratory Fitness.
What interventions are being tested in trial NCT05618574?
The interventions under investigation include: 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK) (DIETARY_SUPPLEMENT), 210 ml of nitrate-depleted placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05618574?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05618574 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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