Low-potassium Content Vegetables in Chronic Kidney Disease

NCT ID: NCT06428942

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

the Recommended Target of Daily Vegetables Intake; Risk of Hyperkalemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

low-potassium vegetables

Intervention Type: OTHER

low-potassium vegetables 3 to 5 serving according to their daily suggested requirement

Control group

The participants in the control group would receive routine CKD dietary education for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

low-potassium vegetables

low-potassium vegetables 3 to 5 serving according to their daily suggested requirement

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Szu-Chun Hung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Szu-Chun Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

Taipei Tzu Chi Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Taipei Tzu Chi Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

TIng-Yun Lin, MD

Role: CONTACT

water_h2o_6@hotmail.com

886-266289779 ext. 2350

Szu-Chun Hung, MD

Role: CONTACT

szuchun.hung@gmail.com

886-266289779 ext. 2350

Facility Contacts

Ting-Yun Lin, MD

Role: primary

water_h2o_6@hotmail.com

8862-6628-9779 ext. 2350

Szu-chun Hung, MD

Role: backup

szuchun.hung@gmail.com

8862-6628-9779 ext. 2350

Szu-Chun Hung, MD

Role: primary

References

Wakasugi M, Yokoseki A, Wada M, Momotsu T, Sato K, Kawashima H, Nakamura K, Onodera O, Narita I. Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. J Ren Nutr. 2023 Jul;33(4):566-574. doi: 10.1053/j.jrn.2023.01.011. Epub 2023 Feb 13.

Reference Type: BACKGROUND

PMID: 36791982 (View on PubMed)

Saglimbene VM, Wong G, Ruospo M, Palmer SC, Garcia-Larsen V, Natale P, Teixeira-Pinto A, Campbell KL, Carrero JJ, Stenvinkel P, Gargano L, Murgo AM, Johnson DW, Tonelli M, Gelfman R, Celia E, Ecder T, Bernat AG, Del Castillo D, Timofte D, Torok M, Bednarek-Skublewska A, Dulawa J, Stroumza P, Hoischen S, Hansis M, Fabricius E, Felaco P, Wollheim C, Hegbrant J, Craig JC, Strippoli GFM. Fruit and Vegetable Intake and Mortality in Adults undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):250-260. doi: 10.2215/CJN.08580718. Epub 2019 Jan 31.

Reference Type: BACKGROUND

PMID: 31738182 (View on PubMed)

Pourafshar S, Sharma B, Kranz S, Mallawaarachchi I, Kurland E, Ma JZ, Scialla JJ. Patterns of Fruit and Vegetable Intake in Adults With and Without Chronic Kidney Disease in the United States. J Ren Nutr. 2023 Jan;33(1):88-96. doi: 10.1053/j.jrn.2022.06.007. Epub 2022 Jul 5.

Reference Type: BACKGROUND

PMID: 35798188 (View on PubMed)

Other Identifiers

12-XD-093

Identifier Type: -

Identifier Source: org_study_id