CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK) +1 moredietary
Likely dose
140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05618574
NCT05618574Phase 2Completed

Nitrite Supplementation to Mitigate Fatigability and Increase Function in Long COVID Patients

VA Office of Research and Development·interventional·Posted Nov 16, 2022·Updated Mar 19, 2025

In Brief

A Phase 2 clinical trial evaluating 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK) and 210 ml of nitrate-depleted placebo for Long COVID and Cardiorespiratory Fitness. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedNov 16, 2022
Enrollment StartDec 1, 2023
Primary CompletionFeb 12, 2025
Study CompletionFeb 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.6 years ago

Interventions

140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK)dietary

The investigators propose to study the benefits nitrite therapeutics, using nitrate-rich beetroot juice to increase serum nitrite. The investigators hypothesize that increased nitrite will improve functional metrics and reduce fatigability in Veterans with long COVID as a result of enhanced skeletal muscle mitochondrial respiration. Participant will receive 140 ml per day of Beet-It nitrate beverage for 16 mmol of nitrate/day for 14 days vs the placebo.

210 ml of nitrate-depleted placebodietary

Participants randomized to the placebo arm will receive 210 ml of nitrate-depleted beverage (cranberry juice) per day for 14 days.