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Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT05050110
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Nand Wadhwa, NY Health d/b/a New York Cancer and Blood Specialists

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Other: Fruits and Vegetable increase Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease Patients Maintaining Normokalemia With Patiromer
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
chronic kidney disease patients
Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer
Other: Fruits and Vegetable increase
Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia




Primary Outcome Measures :
  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. [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. The Kidney Function levels will be tested at each visit from blood samples provided by the subject. [ Time Frame: 3 years ]
    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.


Other Outcome Measures:
  1. Measure the subjects diet intake related to Quality of Life [ Time Frame: 3 years ]
    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.

  2. Measure the description of Daily bowel moments to test for constipation [ Time Frame: 3 years ]
    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. Urine will be measured to evaluate kidney function in subjects with Chronic kidney disease [ Time Frame: 3 years ]
    Tests will include 24 hour urine & Random for sodium, potassium, chloride, magnesium, phosphorus, calcium, urea nitrogen, creatinine, protein, albumin

  4. Measure serum Potassium blood levels to remain below 5mmol/L [ Time Frame: 3 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  1. Patients with a known allergy to patiromer
  2. Patients currently taking patiromer or other potassium controlling agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050110


Contacts
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Contact: Megan Stahl 631-675-5075 mstahl@nycancer.com
Contact: Laura Brady 631-675-5075 lbrady@nycancer.com

Locations
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United States, New York
NY Health Recruiting
Port Jefferson Station, New York, United States, 11776
Contact: Megan Stahl    631-675-5075    mstahl@nycancer.com   
Contact: Laura Brady    631-675-5075    lbrady@nycancer.com   
Principal Investigator: Nand Wadwha, MD         
Sponsors and Collaborators
Nand Wadhwa
Investigators
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Principal Investigator: Nand Wadwha, MD NY Health
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Responsible Party: Nand Wadhwa, Nephrologist, Principal Investigator, NY Health d/b/a New York Cancer and Blood Specialists
ClinicalTrials.gov Identifier: NCT05050110    
Other Study ID Numbers: NYH-01
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency