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This trial will study whether or not daily oral supplementation of nitrate-rich beetroot juice improves vascular, motor, and cognitive function in patients with chronic kidney disease.
- Chronic Kidney Disease
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- Your albumin level is higher than 3.0 grams per deciliter.You are taking warfarin.Your body mass index (BMI) is less than 40 kg/m2.You are not expected to live for more than 1 year.Your blood pressure has been consistently high, with readings above 160/100 mmHg in the past 3 months.You have had a serious liver disease in the past.You have had very serious heart failure with a low ejection fraction.You have an ongoing infection or are currently taking antibiotics.You have had a type of inflammation that affects your blood vessels and required strong medication to suppress your immune system in the last year.You eat a lot of foods with nitrate or take nitrate supplements, or you are very sensitive to nitrate or nitrite.You have a condition called glucose-6-phosphate dehydrogenase deficiency or high levels of methemoglobin in your blood.You have moderate to severe kidney disease, based on a specific test, and your kidney function has been stable for the past 3 months.You need to score higher than 21 on a test to make sure you don't have major memory or thinking problems.Your blood pressure has been consistently higher than 100/60 mmHg for the past 3 months.
- Group 1: Nitrate-rich beetroot juice
- Group 2: Nitrate-depleted beetroot juice
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are there any openings in this research project available to participants?
"Affirmative. The information on clinicaltrials.gov reveals that this research endeavor, first established in May of 2019, is actively recruiting participants. 92 individuals are expected to be recruited from one medical site for the trial."
Has the FDA given authorization to Nitrate-rich beetroot juice?
"There is significant clinical evidence attesting to the safety of nitrate-rich beetroot juice, and thus it earned a rating of 3 on our scale. This treatment has already been approved due to its successful Phase 4 trial."
How many participants are being selected for this clinical experiment?
"Affirmative. The details accessible on clinicaltrials.gov confirms that this experimental research, which was first posted on May 1st 2019, is currently recruiting participants. A total of 92 individuals must be enrolled at one study site."
Who meets the entry criteria for this medical study?
"At this moment, 92 individuals suffering from kidney-related maladies between the ages of 30 and 80 are being enrolled in this clinical trial. Eligible applicants must demonstrate a Mini-mental state examination score greater than 21 for cognitive aptitude screening purposes, have a body mass index lower than 40 kg/m2 to ensure accurate vascular functioning measurements, as well as prove their capacity to complete motor and mental tests (e.g., ascend from seated position without difficulty, traverse 6 minutes on foot or climb 10 stairs)."
Does the trial's protocol include geriatric patients?
"This trial is seeking participants aged between 30 to 80 years old. Separately, 43 studies are dedicated for minors and 457 offer treatment options for individuals over the age of 65."
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