Low-potassium Content Vegetables in Chronic Kidney Disease (LPV in CKD)

May 26, 2024 updated by: Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 231
      • New Taipei City, Taiwan
        • Recruiting
        • Taipei Tzu Chi Hospital
        • Contact:
          • Szu-Chun Hung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CKD stage 3b~5, not yet on dialysis
  • Age ≥20 years
  • Stable doses of medications for 4 weeks
  • Serum potassium level: ≥3.5 and < 5.5 mmol/L

Exclusion Criteria:

  • Anticipated to receive dialysis within 3 month
  • Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
  • Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
  • Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
  • Patients with kidney transplants
  • Patients who receive immunosuppressant
  • Pregnant women or patients who are planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The participants in the intervention group would receive their daily low-potassium vegetables 3 to 5 serving according to their daily suggested requirement and routine CKD dietary education for 8 weeks.
Other: low-potassium vegetables
low-potassium vegetables 3 to 5 serving according to their daily suggested requirement
No Intervention: Control group
The participants in the control group would receive routine CKD dietary education for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who reach the targets of daily vegetable recommended target
Time Frame: 8 weeks
Percentage of participants who reach the targets of daily vegetable recommended
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut-derived uremic toxins
Time Frame: 8 weeks
Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)
8 weeks
Serum creatinine
Time Frame: 8 weeks
Change in serum creatinine in mg/dL
8 weeks
Proteinuria
Time Frame: 8 weeks
Change in proteinuria in g/day
8 weeks
Occurrence of moderate hyperkalemia
Time Frame: 8 weeks
serum [potassium] >=5.5 mmol/L
8 weeks
Gut microbiome
Time Frame: 8 weeks
Change in alpha- and beta-diversities indices
8 weeks
Status of constipation
Time Frame: 8 weeks
Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Principal Investigator: Szu-Chun Hung, MD, Taichung Tzu Chi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 27, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-XD-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not have IPD sharing plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on the Recommended Target of Daily Vegetables Intake

Clinical Trials on low-potassium vegetables

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe