Low Potassium Content Vegetables in End-Stage Renal Disease

NCT04182438 | Unknown

• 1 other identifier: CMUH108-REC3-136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperkalemia is common in End-Stage Renal Disease on chronic hemodialysis patients. The most common cause of mortality in End-Stage Renal Disease patients is sudden cardiac death caused by hyperkalemia. Hyperkalemia also increased urgent dialysis and hospitalization rate. Thus, the management for hyperkalemia in End-Stage Renal Disease patients is crucial, including restricting dietary potassium, medication control, and dialysis dosage adjustment. In the ordinary diet, the significant sources of potassium are vegetables and fruit. In our study, the investigators try to find out the influence of low potassium content vegetables for serum potassium control in End-Stage Renal Disease on chronic hemodialysis patients. This study is a prospective cohort study; the investigators enroll forty End-Stage Renal Disease on hemodialysis patients and perform this study in eight weeks period. The investigators conduct a randomized, double-blind and cross-over trial for investigating the influence of low potassium content vegetables on End-Stage Renal Disease patients. The serum potassium level will record under different potassium content vegetables. The possible adverse effects of low potassium content vegetables, cardiac arrhythmia, will also obtain by chart records during this study.

Conditions

End-stage Renal Disease

Keywords

Low potassium content vegetables; End-Stage Renal Disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change of serum potassium level

  Measure pre-dialysis serum potassium

  two weeks

Study Arms (2)

Low potassium then normal potassium

EXPERIMENTAL

After giving the vegetables with low potassium content vegetables for 2 weeks, the serum potassium level was recorded; after 2 weeks of washing time, the normal potassium content vegetables was given for 2 weeks, and the serum potassium concentration was recorded and the test was terminated.

Dietary Supplement: Low potassium content vegetables

Normal potassium then low potassium

EXPERIMENTAL

After giving the normal potassium content vegetables for 2 weeks, the serum potassium concentration was recorded; after 2 weeks of washing time, the low potassium content vegetables use for 2 weeks, then the serum potassium level was recorded at the time. The test was terminated.

Dietary Supplement: Low potassium content vegetables

Interventions

Low potassium content vegetables DIETARY_SUPPLEMENT

use low-potassium content vegetables

Low potassium then normal potassium; Normal potassium then low potassium

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-Stage Renal Disease on chronic hemodialysis patients in single center

You may not qualify if:

• younger than 20 years old, the pregnant woman

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Asia University Hospital

Taichung, 413, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Central Study Contacts

Hsuan-Jen Lin, MD

CONTACT

+886976555706; beardogeli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology physician doctor

Model Details: This study will enroll 40 End-Stage Renal Disease on chronic hemodialysis patients. We will perform a randomized, double-blind, cross over study. In one group, low potassium content vegetables use as study intervention for two weeks (study phase), then shift to placebo (ordinary vegetables) for two weeks. In another group, ordinary vegetables will use firstly, then change to low potassium content vegetable use. Serum potassium, blood pressure, and biochemistries will analyze at the end of the study.

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: January 2, 2020
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)