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The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.(KS01)

Not Applicable
Completed
Conditions
Chronic Kidney Disease (CKD)
Registration Number
NCT06568991
Lead Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
127
Inclusion Criteria

Exclusion criterias<br><br> 1. were undergoing dialysis<br><br> 2. had cancer under any treatmen<br><br> 3. had any major surgery before or after the study period<br><br> 4. were pregnant or breastfeeding<br><br> 5. were diagnosed with alcoholism<br><br> 6. had liver, gastrointestinal tract, or other metabolic diseases<br><br> 7. and/or had been determined by a physician to be clinically unstable.<br><br> 8. Subject is participating in another study that has not been approved as a<br> concomitant study by Low Protein Rice.<br><br> 9. Subjects consuming oral nutritional supplement(ONS) >3 times/week for the control<br> group and subjects consuming any ONS for the low protein rice group.<br><br>Inclusion criteria<br><br> 1. Patients were diagnosed with stages 3b-5 CKD with an estimated glomerular filtration<br> rate (eGFR) of 15-44 mL/min/1.73 m2.<br><br> 2. Patients were aged 30-70 years<br><br> 3. Patients received pre-end-stage renal disease (pre-ESRD) care under a<br> pay-for-performance program (P4P) at the Department of Nephrology at Kaohsiung<br> Medical University Hospital.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
albumin (g/dL);nitrogen balance (g/day);handgrip strength (kg);blood urea nitrogen (mg/dL);creatinine (mg/dL);estimated glomerular filtration rate (eGFR) (mL/min/1.73m2)
Secondary Outcome Measures
NameTimeMethod
Body weight (kg);muscle mass (kg);fat mass (%);energy intake (Kcal/day);protein intake (g/day);potassium (mmol/L);phosphorus (mg/dL)
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