13 Participants Needed

Diet Modification for Chronic Kidney Disease

LB
MS
Overseen ByMegan Stahl
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nand Wadhwa
Must be taking: Patiromer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to investigate the feasibility of increasing dietary consumption of a rich variety of fruits and vegetables (including those that are potassim-rich) in patients with chronic kidney disease through use of nutritional counselling and hyperkalemia management with patiromer

Will I have to stop taking my current medications?

The trial requires that if you are taking RASS inhibitors, beta-blockers, or diuretics, you must be on stable doses for 2 weeks. If you are taking other potassium controlling agents, you cannot participate in the trial.

Is increasing fruit and vegetable intake safe for people with chronic kidney disease?

Increasing fruit and vegetable intake is generally safe for most people, but those with advanced chronic kidney disease should be cautious due to the risk of hyperkalemia (high potassium levels in the blood). However, studies suggest that a balanced intake can be beneficial and may reduce the risk of disease progression and other health issues.12345

How does increasing fruits and vegetables differ from other treatments for chronic kidney disease?

Increasing fruits and vegetables in the diet for chronic kidney disease is unique because it helps neutralize metabolic acidosis (a condition where the body produces too much acid) and reduces harmful toxins, unlike traditional diets that limit these foods due to high potassium content. This approach also lowers phosphorus absorption, reducing cardiovascular risks, and provides essential nutrients like magnesium and vitamin K, which are often deficient in these patients.15678

What data supports the effectiveness of the treatment Fruits and Vegetable increase for Chronic Kidney Disease?

Increasing fruit and vegetable intake may help reduce the risk of end-stage kidney disease, as suggested by research evaluating this relationship in adults with chronic kidney disease.125910

Who Is on the Research Team?

NW

Nand Wadwha, MD

Principal Investigator

NY Health

Are You a Good Fit for This Trial?

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.

Inclusion 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.
Diet evaluation for hyperkalemia (serum potassium ≥ 5.0) during the last 90 days
See 3 more

Exclusion Criteria

Patients with a known allergy to patiromer
I am currently taking medication to control my potassium levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants document their normal daily consumption of fruits and vegetables in a food diary while taking Patiromer (Veltassa) daily

2 weeks
1 visit (in-person)

Dietary Intervention

Participants receive dietary/nutritional counseling and increase their fruit and vegetable intake, documenting choices in food diaries

50 weeks
Regular visits (in-person) up to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued use of Veltassa at the discretion of the investigator

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fruits and Vegetable increase
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nand Wadhwa

Lead Sponsor

Trials
1
Recruited
10+

Citations

Patterns of Fruit and Vegetable Intake in Adults With and Without Chronic Kidney Disease in the United States. [2023]
Dietary Factors and Prevention: Risk of End-Stage Kidney Disease by Fruit and Vegetable Consumption. [2023]
Systematic Review and Meta-analyses: Dietary Behavior Interventions in Non-dialysis Chronic Kidney Disease. [2021]
Development and Relative Validity of the Chronic Kidney Disease Short Food Frequency Questionnaire (CKD SFFQ) to Determine Diet Quality and Dietary Habits among Adults with Chronic Kidney Disease. [2021]
Nutritional status, hyperkalaemia and attainment of energy/protein intake targets in haemodialysis patients following plant-based diets: a longitudinal cohort study. [2021]
The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial. [2023]
Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. [2023]
Vegetable-Based Diets for Chronic Kidney Disease? It Is Time to Reconsider. [2023]
Dietary interventions for adults with chronic kidney disease. [2023]
Reduction of potassium content of green bean pods and chard by culinary processing. Tools for chronic kidney disease. [2017]
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