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NCT04546958Completed

Nutritional Interventions in Peritoneal Dialysis Patients with Hypoalbuminemia

Clinical Implication of Nutritional Counseling and Whey Protein Supplements in Patients on Peritoneal Dialysis with Hypoalbuminemia

Source: ClinicalTrials.gov · Last updated 25 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
33 (actual)
First submitted
6 Sept 2020
Start date
2 Oct 2020
Primary completion date
31 Oct 2023
Lead sponsor
Far Eastern Memorial Hospital
NCT number
NCT04546958

What you commit to

  • Study type: Interventional
  • Participants enrolled: 33
  • From 2 Oct 2020 to the primary completion date, 31 Oct 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Having active infection or inflammation
  • Having gastrointestinal bleeding
  • History of psychiatric disorders

Other

  • Untreated fluid overload
  • Uncorrected metabolic acidosis
  • Hospitalization within the past 4 weeks
  • those who cannot cooperate with the dietary record
  • those who have poor adherence to whey protein consumption
  • Having mental retardation

Who the study is looking for

  • 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

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Far Eastern Memorial Hospital
Coordinator of this site? Confirm its status
New Taipei CityTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.