Clinical trial NCT06428942: Low-potassium Content Vegetables in Chronic Kidney Disease
Official title: Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: the Recommended Target of Daily Vegetables Intake
Risk of Hyperkalemia
Keywords: chronic kidney disease
vegetables
hyperkalemia
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to intervention group or control group with ratio of 50:25.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percentage of participants who reach the targets of daily vegetable recommended target
timeFrame: 8 weeks
Secondary outcomes:
measure: Gut-derived uremic toxins
timeFrame: 8 weeks
measure: Serum creatinine
timeFrame: 8 weeks
measure: Proteinuria
timeFrame: 8 weeks
measure: Occurrence of moderate hyperkalemia
timeFrame: 8 weeks
measure: Status of constipation
timeFrame: 8 weeks
measure: Gut microbiome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Szu-Chun Hung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.