Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease Patients Maintaining Normokalemia With Patiromer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050110
• Other study ID #: NYH-01
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: NY Health d/b/a New York Cancer and Blood Specialists
• Contact: Megan Stahl
• Phone: 631-675-5075
• Email: mstahl[@]nycancer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Adult Patients ages 18 and older with a diagnosis of Chronic Kidney Disease will be given a Diet Plan that consist of an increase of Fruits and Vegetables. Baseline data will be collected after the subject has signed the consent and their most recent eGFR and potassium level that is within 90 days has been reviewed to determine they are within the inclusion criteria.

Based on the approved Patiromer (Veltassa) package insert the subject will begin to take daily. During this control period of two weeks, the subject will document their normal daily consumption of fruits and vegetables in a provided food diary.

On the Second week, patient will receive dietary/nutritional counseling on the importance of potassium-rich fruits and vegetables. They will be instructed to increase their fruit and vegetable intake based on personal preferences and nutritional guides located inside the food diary. Choices will be documented daily in the supplied food diaries.

The Bowel Diary will be classified according to the Bristol Stool Chart and Quality of Life. Nutrition Survey Questionnaire will be documented in that supplied log.

At each subsequent visit, food diaries will be reviewed to evaluate fruit and vegetable consumption, vital signs will be documented and labs collected to measure effects on potassium metabolism. Bowel habits and questionnaires will be completed by the subject to determine how their diet has affected their quality of life.

Patiromer (Veltessa) dosing will be adjusted based on their serum potassium values following the approved drug brochure guidelines and at the discretion of the investigator.

Subject will return to the clinic at specified time points up to 52 weeks on study. The Patient can continue Veltassa while in the follow up period until week 52 at the discretion of the Principle Investigator.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients = 18 years of age with chronic kidney disease and hyperkalemia

2. Chronic kidney disease is defined as eGFR 15-44ml/min/1.73m2

3. Documented hyperkalemia which is defined as serum potassium = 5.0 mmol/L during the last 90 days

4. Diet evaluation for hyperkalemia (serum potassium = 5.0) during the last 90 days

5. Patients receiving RASS inhibitors, beta-blockers, or diuretics to be on stable doses for 2 weeks

6. Patients already receiving patiromer are eligible

Exclusion Criteria:

1. Patients with a known allergy to patiromer

2. Patients currently taking other potassium controlling agents.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Fruits and Vegetable increase
Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia

Locations

Country	Name	City	State
United States	NY Health	Port Jefferson Station	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nand Wadhwa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure the subjects diet intake related to Quality of Life	The subject will complete a Quality of Life Nutritional Questionnaire which is an instrument supported by ncbi to assess quality of life in relation to nutrition.	3 years
Other	Measure the description of Daily bowel moments to test for constipation	Patient will complete a daily bowel Diary based on the Bristol Stool Chart which is a medical aid designed to classify feces into seven groups. The Diary will be provided to the subject to observe and classify their daily bowel movements.	3 years
Other	Urine will be measured to evaluate kidney function in subjects with Chronic kidney disease	Tests will include 24 hour urine & Random for sodium, potassium, chloride, magnesium, phosphorus, calcium, urea nitrogen, creatinine, protein, albumin	3 years
Other	Measure serum Potassium blood levels to remain below 5mmol/L	Serum Potassium levels are measured by blood samples from the subject that consists of either A Comprehensive Metabolic Panel blood test which includes or Basic Metabolic Panel depending on the timepoint in the study.	3 years
Primary	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	The Kidney Function levels will be tested at each visit from blood samples provided by the subject.	The Kidney Function blood test samples will be taken from the subject to show overall kidney health in Chronic Kidney Disease Patients by increasing their fruit and vegetable intake while on patiromer. The blood tests that support this is , Magnesium, phosphorus, iPTH, lipid panel, uric acid, hemoglobin A1C, Vitamin D 25(OH), Vitamin D 1,25(OH), FGF-23 and CBC panel.	3 years