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Fish Oil and HDL Function in Patients on Maintenance Hemodialysis

NCT07730385 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-04

No results posted yet for this study

Summary

Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. A recent clinical trial (PISCES) found that high-dose omega-3 fatty acids (fish oil) reduced cardiovascular events in hemodialysis patients, but the reason for this benefit is not understood.

One possible explanation is that, in kidney failure, high-density lipoprotein (HDL) no longer works normally. This study investigates whether omega-3 fatty acid supplementation improves the function of HDL in people on maintenance hemodialysis.

Forty adults on maintenance hemodialysis will take part. Each participant receives fish oil (4 g per day) for 8 weeks and also has an 8-week period without supplementation; participants are randomly assigned to the order of these two periods (crossover design), for a total of 16 weeks each. The main measure is cholesterol efflux capacity, a laboratory test of how well HDL removes cholesterol from cells. The study also examines other markers of HDL quality.

This is an exploratory, mechanistic study. Its aim is to determine whether omega-3 fatty acids change HDL function and to inform the design of larger future trials.

Conditions

Interventions

DIETARY_SUPPLEMENT

n-3 PUFA (fish oil)

4g/day fish oil (four 1 g capsules) providing approximately 1.6 g EPA and 0.8 g DHA, taken for 8 weeks, matching the PISCES dose

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Austria

Study Locations

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Entities

Diseases

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 NCT07730385 on ClinicalTrials.gov