Fish Oil and HDL Function in Patients on Maintenance Hemodialysis

Sponsor
Medical University of Vienna
Study ID
NCT07730385
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Disease
  • HDL Cholesterol
  • Kidney Failure Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • n-3 PUFA (fish oil) — DIETARY_SUPPLEMENT
    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

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Group A: n-3 PUFA then off-treatment
    Participants receive n-3 PUFA supplementation (4 g/day fish oil) for 8 weeks, followed by an 8-week off-treatment period.
  • Experimental: Group B: off-treatment then n-3 PUFA
    Participants undergo an 8-week off-treatment period, followed by 8 weeks of n-3 PUFA supplementation (4 g/day fish oil).

Primary Outcome Measure

Cholesterol Efflux Capacity (CEC) [ Time Frame: Weeks 1, 8, and 16 ]

Central Contacts

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