Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease

NCT05050110 | Active Not Recruiting

• 1 other identifier: NYH-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will increase the Fruit and vegetable consumption by following a Diet plan listed in the Nutritional Diary provided to them by the study site in the beginning of the study while taking Patiromer (Veltassa). This will record their daily intake of 26-28 servings of fruit and vegetables weekly. The Nutritional diary lists a Diet Plan that measures the serving size of 26-28 servings of the fruits and vegetables. The measurement of fruits and vegetables has been calculated by the Nutritionist based off of the USDA Nutritive Value of foods and listed on the diary to explain the serving sizes and suggestions of meal plans.

  3 years

Secondary Outcomes (1)

• The Kidney Function levels will be tested at each visit from blood samples provided by the subject.

  3 years

Other Outcomes (4)

• Measure the subjects diet intake related to Quality of Life

  3 years

• Measure the description of Daily bowel moments to test for constipation

  3 years

• Urine will be measured to evaluate kidney function in subjects with Chronic kidney disease

  3 years

Study Arms (1)

chronic kidney disease patients

OTHER

Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer

Other: Fruits and Vegetable increase

Interventions

Fruits and Vegetable increase OTHER

Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia

chronic kidney disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 years of age with chronic kidney disease and hyperkalemia
• Chronic kidney disease is defined as eGFR 15-44ml/min/1.73m2
• Documented hyperkalemia which is defined as serum potassium ≥ 5.0 mmol/L during the last 90 days
• Diet evaluation for hyperkalemia (serum potassium ≥ 5.0) during the last 90 days
• Patients receiving RASS inhibitors, beta-blockers, or diuretics to be on stable doses for 2 weeks
• Patients already receiving patiromer are eligible

You may not qualify if:

• Patients with a known allergy to patiromer
• Patients currently taking other potassium controlling agents.

Sponsors & Collaborators

• Nand Wadhwa: lead

Study Sites (1)

NY Health

Port Jefferson Station, New York, 11776, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Fruit

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nand Wadwha, MD

  NY Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nephrologist, Principal Investigator

Model Details: Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: September 20, 2021
• Study Start: November 24, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

US (1)