Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease
NCT ID: NCT05050110
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
13 participants
INTERVENTIONAL
2020-11-24
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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chronic kidney disease patients
Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer
Fruits and Vegetable increase
Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia
Interventions
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Fruits and Vegetable increase
Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia
Eligibility Criteria
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Inclusion Criteria
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
2. Patients currently taking other potassium controlling agents.
18 Years
ALL
No
Sponsors
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Nand Wadhwa
OTHER
Responsible Party
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Nand Wadhwa
Nephrologist, Principal Investigator
Principal Investigators
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Nand Wadwha, MD
Role: PRINCIPAL_INVESTIGATOR
NY Health
Locations
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NY Health
Port Jefferson Station, New York, United States
Countries
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Other Identifiers
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NYH-01
Identifier Type: -
Identifier Source: org_study_id
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