Risk of Hyperkalemia, the Recommended Target of Daily Vegetables Intake
Conditions
Keywords
chronic kidney disease, vegetables, hyperkalemia
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.
Interventions
OTHERlow-potassium vegetables
low-potassium vegetables 3 to 5 serving according to their daily suggested requirement
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Masking is not allowed in this study
Intervention model description
Participants are randomized to intervention group or control group with ratio of 50:25.
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who reach the targets of daily vegetable recommended target | 8 weeks | Percentage of participants who reach the targets of daily vegetable recommended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | 8 weeks | Change in serum creatinine in mg/dL |
| Proteinuria | 8 weeks | Change in proteinuria in g/day |
| Gut-derived uremic toxins | 8 weeks | Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate) |
| Status of constipation | 8 weeks | Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome. |
| Gut microbiome | 8 weeks | Change in alpha- and beta-diversities indices |
| Occurrence of moderate hyperkalemia | 8 weeks | serum \[potassium\] \>=5.5 mmol/L |
Countries
Taiwan
Contacts
Primary ContactTIng-Yun Lin, MD
Backup ContactSzu-Chun Hung, MD
Outcome results
None listed