the Recommended Target of Daily Vegetables IntakeLPV in CKDNCT06428942
Low-potassium Content Vegetables in Chronic Kidney Disease
A study testing low-potassium vegetables in people with the Recommended Target of Daily Vegetables Intake and Risk of Hyperkalemia, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- the Recommended Target of Daily Vegetables Intake, Risk of Hyperkalemia
- What is being tested?
- low-potassium vegetables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesTaiwan
- Study dates
- 27 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City, 231
Ting-Yun Lin, MD, 8862-6628-9779 ext. 2350, water_h2o_6@hotmail.com
Szu-chun Hung, MD, 8862-6628-9779 ext. 2350, szuchun.hung@gmail.com
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City
Szu-Chun Hung, MD
About this study
Official title: Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- low-potassium vegetables
- Keywords
- chronic kidney disease, vegetables, hyperkalemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-potassium vegetablesOther
low-potassium vegetables 3 to 5 serving according to their daily suggested requirement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: low-potassium vegetables |
| Control group | No intervention | The participants in the control group would receive routine CKD dietary education for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who reach the targets of daily vegetable recommended target
Percentage of participants who reach the targets of daily vegetable recommended
Measured: 8 weeks
Secondary outcomes (6)
Gut-derived uremic toxins
Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)
Measured: 8 weeks
Serum creatinine
Change in serum creatinine in mg/dL
Measured: 8 weeks
Proteinuria
Change in proteinuria in g/day
Measured: 8 weeks
Occurrence of moderate hyperkalemia
serum [potassium] >=5.5 mmol/L
Measured: 8 weeks
Status of constipation
Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.
Measured: 8 weeks
Gut microbiome
Change in alpha- and beta-diversities indices
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start27 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for the Recommended Target of Daily Vegetables IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to intervention group or control group with ratio of 50:25.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Szu-Chun Hung, MD, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428942
- Sponsor's protocol ID
- 12-XD-093
- Acronym
- LPV in CKD
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have IPD sharing plan.
Publications
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.
PubMed 36791982Saglimbene 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.
PubMed 31738182Pourafshar 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.
PubMed 35798188
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06428942
- Acronym / sponsor ID
- LPV in CKD / 12-XD-093
- Keywords
- chronic kidney disease, vegetables, hyperkalemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to intervention group or control group with ratio of 50:25.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: low-potassium vegetablesThe 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. |
| Control group | No intervention | –The participants in the control group would receive routine CKD dietary education for 8 weeks. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-potassium vegetableslow-potassium vegetables 3 to 5 serving according to their daily suggested requirement | Other | Intervention group |
Primary outcome
Percentage of participants who reach the targets of daily vegetable recommended target
Time frame: 8 weeks
Percentage of participants who reach the targets of daily vegetable recommended
6 secondary outcomes
Gut-derived uremic toxins
Time frame: 8 weeks
Serum creatinine
Time frame: 8 weeks
Proteinuria
Time frame: 8 weeks
Occurrence of moderate hyperkalemia
Time frame: 8 weeks
Status of constipation
Time frame: 8 weeks
Gut microbiome
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 36791982Wakasugi 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.
- Background: PubMed 31738182Saglimbene 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.
- Background: PubMed 35798188Pourafshar 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.
- Individual participant dataSharing planned: No. We do not have IPD sharing plan.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Chun Hung, MD principal investigator
Taichung Tzu Chi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-potassium vegetables in people with the Recommended Target of Daily Vegetables Intake and Risk of Hyperkalemia, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TIng-Yun Lin, MD (886-266289779 ext. 2350, water_h2o_6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who reach the targets of daily vegetable recommended target (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428942, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.