Nutritional Interventions in Peritoneal Dialysis Patients with Hypoalbuminemia

NCT04546958 | Completed

• 1 other identifier: FEMH-IRB-109116-F
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Concentrations of albumin (g/dL)

  Difference in change-from-baseline albumin (g/dL) between two intervention arms

  3 months

Secondary Outcomes (19)

• Concentrations of pre-albumin (g/dL)

  3 months

• Concentrations of C-reactive protein (mg/dL)

  3 months

• Concentrations of phosphate (mg/dL)

  3 months

• Concentrations of blood urea nitrogen (mg/dL)

  3 months

• Concentrations of free indoxyl sulfate (mg/L)

  3 months

Study Arms (2)

Nutritional counseling arm

ACTIVE COMPARATOR

Nutritional counseling, targeting daily protein intake 1.2 g/kg Dietitian will provide one-to-one dietary education, 30 minutes duration, on a monthly basis

Other: Nutritional counseling

Nutritional counseling plus whey protein supplements arm

EXPERIMENTAL

Nutritional counseling plus whey protein supplements, targeting daily protein intake 1.5 g/kg In addition to receiving nutritional counseling, participants are instructed to take an additional whey protein supplement at the dose of \~0.3 g/kg protein intake.

Dietary Supplement: Whey protein supplements; Other: Nutritional counseling

Interventions

Whey protein supplements DIETARY_SUPPLEMENT

Nutritional counseling and whey protein supplements for 3 months

Nutritional counseling plus whey protein supplements arm

Nutritional counseling OTHER

Nutritional counseling by dietitians for 3 months

Nutritional counseling arm; Nutritional counseling plus whey protein supplements arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged greater than or equal to 20 years
• Having end-stage kidney disease and having undergone maintenance PD for more than three months
• Having adequate dialysis (weekly Kt/V greater than or equal to 1.7)
• Serum albumin levels lower than 4.0 g/dL, measured by bromocresol green assay

You may not qualify if:

• Untreated fluid overload
• Uncorrected metabolic acidosis
• Having active infection or inflammation
• Hospitalization within the past 4 weeks
• Having gastrointestinal bleeding
• those who cannot cooperate with the dietary record
• those who have poor adherence to whey protein consumption
• History of psychiatric disorders
• Having mental retardation

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Wan-Chuan Tsai, M.D., Ph.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians who assess the study outcomes will be masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: A randomized, active-controlled trial with cross-over design

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 14, 2020
• Study Start: October 2, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available after completing the study for 1 year and for 3 years after formal publication.
• Access Criteria: Data will be made available by the corresponding author of the paper upon request by email.

Locations

TW (1)