## Protocol Section
### Identification Module
**NCT ID:** NCT06428942

**Acronym:** LPV in CKD

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 12-XD-093
#### Organization
**Class:** OTHER
**Full Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-27

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

#### Responsible Party

**Investigator Affiliation:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

**Investigator Full Name:** Szu-Chun Hung

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- the Recommended Target of Daily Vegetables Intake

- Risk of Hyperkalemia

**Keywords:**

- chronic kidney disease

- vegetables

- hyperkalemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** NONE

**Masking Description:** Masking is not allowed in this study

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: low-potassium vegetables

**Label:** Intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

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

**Name:** low-potassium vegetables

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants who reach the targets of daily vegetable recommended

**Measure:** Percentage of participants who reach the targets of daily vegetable recommended target

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)

**Measure:** Gut-derived uremic toxins

**Time Frame:** 8 weeks

**Description:** Change in serum creatinine in mg/dL

**Measure:** Serum creatinine

**Time Frame:** 8 weeks

**Description:** Change in proteinuria in g/day

**Measure:** Proteinuria

**Time Frame:** 8 weeks

**Description:** serum \[potassium\] \>=5.5 mmol/L

**Measure:** Occurrence of moderate hyperkalemia

**Time Frame:** 8 weeks

**Description:** Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.

**Measure:** Status of constipation

**Time Frame:** 8 weeks

**Description:** Change in alpha- and beta-diversities indices

**Measure:** Gut microbiome

**Time Frame:** 8 weeks

### Eligibility Module

**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

**Maximum Age:** 99 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** water_h2o_6@hotmail.com

**Name:** TIng-Yun Lin, MD

**Phone:** 886-266289779

**Phone Ext:** 2350

**Role:** CONTACT

**Contact 2:**

**Email:** szuchun.hung@gmail.com

**Name:** Szu-Chun Hung, MD

**Phone:** 886-266289779

**Phone Ext:** 2350

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Taipei City

**Contacts:**

***Contact 1:***

- **Email:** water_h2o_6@hotmail.com

- **Name:** Ting-Yun Lin, MD

- **Phone:** 8862-6628-9779

- **Phone Ext:** 2350

- **Role:** CONTACT

***Contact 2:***

- **Email:** szuchun.hung@gmail.com

- **Name:** Szu-chun Hung, MD

- **Phone:** 8862-6628-9779

- **Phone Ext:** 2350

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Taipei Tzu Chi Hospital

**Status:** RECRUITING

**Zip:** 231

**Location 2:**

**City:** New Taipei City

**Contacts:**

***Contact 1:***

- **Name:** Szu-Chun Hung, MD

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Taipei Tzu Chi Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Taichung Tzu Chi Hospital

**Name:** Szu-Chun Hung, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** We do not have IPD sharing plan.

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 36791982

**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.

**PMID:** 31738182

**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.

**PMID:** 35798188

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014883

- Term: Water-Electrolyte Imbalance

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M9998

- Name: Hyperkalemia

- Relevance: HIGH

- As Found: Hyperkalemia

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M17624

- Name: Water-Electrolyte Imbalance

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000006947

- Term: Hyperkalemia

### Misc Info Module

- Version Holder: 2024-05-31
