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Nutritional Interventions in Peritoneal Dialysis Patients with Hypoalbuminemia

NCT04546958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-02-25

No results posted yet for this study

Summary

Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in patients on peritoneal dialysis (PD). The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known. The investigators hypothesize that higher dietary protein intake has a greater beneficial effect on nutritional status in hypoalbuminemic PD patients. In particular, 1.5 g/kg protein intake provides a better beneficial effect than 1.2 g/kg protein intake.

Conditions

  • End Stage Renal Disease on Dialysis

Interventions

DIETARY_SUPPLEMENT

Whey protein supplements

Nutritional counseling and whey protein supplements for 3 months

OTHER

Nutritional counseling

Nutritional counseling by dietitians for 3 months

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Wan-Chuan Tsai, M.D., Ph.D. · Far Eastern Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2023-10-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546958 on ClinicalTrials.gov