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Dietary Supplement
Nitrate Supplement for Long COVID
Phase 2
Recruiting
Led By Daniel E Forman, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inclusion limited to age 18 and over
Be older than 18 years old
Must not have
Current use of organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors
Orthopedic or other chronic condition which limits physical activity or functional testing assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Summary
This trial will study how a juice supplement can help people with Long COVID improve strength, balance, and aerobic capability with physical therapy.
Who is the study for?
This trial is for veterans over 18 who've had COVID-19 and are now experiencing long-term fatigue and reduced physical activity. They must not have low blood pressure, be able to pause certain medications before a muscle biopsy, give informed consent, and should not have conditions that limit their movement or other serious health issues.
What is being tested?
The study tests if drinking Beet-It nitrate juice daily can help improve muscle function in Long COVID patients compared to a placebo drink. All participants will also receive physical therapy aimed at enhancing strength and aerobic capacity over two weeks.
What are the potential side effects?
While the trial description does not specify side effects of the Beet-It beverage, potential general side effects may include changes in blood pressure or interactions with certain medications due to its nitrate content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for heart problems or erectile dysfunction.
Select...
I have a chronic condition that limits my physical activity.
Select...
I am capable of understanding and giving informed consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigability
Walking Efficiency
Secondary outcome measures
Walk Test
Mitochondrial Respiration
Oxygen
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Beet-It nitrate beverageActive Control1 Intervention
Participant will receive 210 ml per day of Beet-It nitrate beverage for 16 mmol of nitrate/day for 14. All participants will undergo physical therapy 2-3 times per week based on tolerance for activity and recovery needed after each session. Physical therapy will be standardized to include strength, balance, inspiratory muscle training, and aerobic training.
Group II: Nitrate-depleted placebo.Placebo Group1 Intervention
Participants will receive 210 ml of nitrate-depleted placebo for 14 days. All participants will undergo physical therapy 2-3 times per week based on tolerance for activity and recovery needed after each session. Physical therapy will be standardized to include strength, balance, inspiratory muscle training, and aerobic training.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,030 Total Patients Enrolled
University of PittsburghOTHER
1,762 Previous Clinical Trials
16,347,963 Total Patients Enrolled
Daniel E Forman, MDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 Previous Clinical Trials
265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is lower than 110/60 mmHg.I have a chronic condition that limits my physical activity.I am a veteran with long COVID, feeling very tired and less active than before.I am currently taking medication for heart problems or erectile dysfunction.I do not use anti-bacterial mouthwash or antacids that affect the nitrate pathway.I cannot stop taking blood thinners or aspirin for a few days before a muscle biopsy.I am 18 years old or older.I am capable of understanding and giving informed consent.You have a mental health condition that is not currently under control.You have a very advanced stage of the disease.You have a history of heavy drinking or substance abuse.I regularly take oral steroids or medications that affect muscle function.Your hemoglobin level is lower than 11.0 g/dL or 10.0 g/dL
Research Study Groups:
This trial has the following groups:- Group 1: Beet-It nitrate beverage
- Group 2: Nitrate-depleted placebo.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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