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Diet Modification for Chronic Kidney Disease
N/A
Recruiting
Led By Nand Wadwha, MD
Research Sponsored by Nand Wadhwa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial looks at whether patients with chronic kidney disease can improve their health by increasing their intake of fruits and vegetables rich in potassium, with the help of a nutritional counselor and a potassium-binding medication.
Who is the study for?
This trial is for adults over 18 with chronic kidney disease (eGFR 15-44ml/min/1.73m2) and high potassium levels in their blood (≥5.0 mmol/L). They should be on stable doses of certain heart or blood pressure medicines for at least two weeks. People allergic to patiromer or already taking potassium controlling drugs can't join.Check my eligibility
What is being tested?
The study tests if eating more fruits and vegetables, including those high in potassium, helps people with chronic kidney disease. It includes nutritional advice and managing high potassium levels using a drug called patiromer.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to increased fiber from fruits and vegetables, as well as any reactions related to the use of patiromer for managing hyperkalemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
By increasing the consumption of Fruits and Vegetable in their daily diet using the Nutritional Fruits and Vegetable Diary based off of the USDA Nutritive Value of foods and completing the Quality of Life Nutritional Questionnaire.
Secondary outcome measures
The Kidney Function levels will be tested at each visit from blood samples provided by the subject.
Other outcome measures
Measure serum Potassium blood levels to remain below 5mmol/L
Measure the description of Daily bowel moments to test for constipation
Measure the subjects diet intake related to Quality of Life
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: chronic kidney disease patientsExperimental Treatment1 Intervention
Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer
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Who is running the clinical trial?
Nand WadhwaLead Sponsor
Nand Wadwha, MDPrincipal InvestigatorNY Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 with chronic kidney disease and high potassium levels.I have been on a stable dose of RASS inhibitors, beta-blockers, or diuretics for 2 weeks.My kidney function is low, with an eGFR between 15-44.I am currently taking medication to control my potassium levels.I am currently taking patiromer.
Research Study Groups:
This trial has the following groups:- Group 1: chronic kidney disease patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being accepted for this trial?
"On clinicaltrials.gov, this medical trial is documented as actively searching for participants; initial postings date back to November 24th 2020 with recent updates on September 26th 2022."
Answered by AI
How many individuals are included in the current research project?
"Affirmative, clinicaltrials.gov indicates that this trial has been actively enrolling since November 24th 2020 and was recently updated on September 26th 2022. As such, it is currently searching for 40 participants at a single location."
Answered by AI
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