Nitrite Supplementation in Long COVID Patients

RECRUITING

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Potential benefits of a nitrate 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.

Conditions:

🦠 Long COVID 🦠 Cardiorespiratory Fitness

🗓️ Study Start (Actual) 1 December 2023

🗓️ Primary Completion (Estimated) 1 August 2024

✅ Study Completion (Estimated) 28 February 2025

👥 Enrollment (Estimated) 40

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Veterans with prior COVID-19, with residual symptoms of long COVID including increased fatigability (i.e., RPE 10 during steady-state walking and reduced physical activity (\<8 Mets/day)).
* Inclusion limited to age 18 and over

Exclusion Criteria:

* Blood pressure \<110/60 mmHg, either systolic or diastolic value
* Unable to hold warfarin, novel oral anticoagulants (NOACs) or aspirin for 3 days prior to muscle biopsy, or to hold thienopyridine medications for 5 days prior to muscle biopsy
* Current use of organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors
* Orthopedic or other chronic condition which limits physical activity or functional testing assessments
* End-stage disease
* Dementia or other reason unable to give informed consent
* Anemia (hemoglobin \<11.0 g/dL or \<10.0 g/dL)
* Unstable psychiatric diagnosis
* Clinically significant alcohol intake (CAGE score 2 or \>) or substance abuse
* Chronic use of oral corticosteroids or medications that affect muscle function
* Use of anti-bacterial mouthwash or antacids that confound the nitrate/nitrite/NO pathway.
* Involved in another greater than minimal risk study

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 14 November 2022
First Submitted that Met QC Criteria 14 November 2022
First Posted 16 November 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 5 December 2023
Last Update Posted 12 December 2023
Last Verified December 2023