Low-potassium Content Vegetables in Chronic Kidney Disease

NCT06428942 | Recruiting

• 1 other identifier: 12-XD-093
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

the Recommended Target of Daily Vegetables Intake; Risk of Hyperkalemia

Keywords

chronic kidney disease; vegetables; hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who reach the targets of daily vegetable recommended target

  Percentage of participants who reach the targets of daily vegetable recommended

  8 weeks

Secondary Outcomes (6)

• Gut-derived uremic toxins

  8 weeks

• Serum creatinine

  8 weeks

• Proteinuria

  8 weeks

• Occurrence of moderate hyperkalemia

  8 weeks

• Status of constipation

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

low-potassium vegetables OTHER

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

Intervention group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (2)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

RECRUITING

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 36791982 BACKGROUND

• 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.

  PMID: 31738182 BACKGROUND

• 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.

  PMID: 35798188 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Condition Hierarchy (Ancestors)

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; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Szu-Chun Hung, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TIng-Yun Lin, MD

CONTACT

886-266289779; water_h2o_6@hotmail.com

Szu-Chun Hung, MD

CONTACT

886-266289779; szuchun.hung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not allowed in this study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized to intervention group or control group with ratio of 50:25.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: May 27, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)