Fish Oil and HDL Function in Patients on Maintenance Hemodialysis

NCT07730385 | Not Yet Recruiting

• 1 other identifier: EK Nr: 1072/202 (EFFLUX-HD)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Kidney Failure Chronic; HDL Cholesterol; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Cholesterol Efflux Capacity (CEC)

  Cholesterol efflux capacity of apolipoprotein B-depleted serum, measured with a cell-based fluorescent assay and reported as percentage cholesterol efflux (%).

  Weeks 1, 8, and 16

Secondary Outcomes (2)

• Serum Amyloid A (SAA)

  Weeks 1, 8, and 16

• Biologically Effective HDL

  Weeks 1, 8, and 16

Study Arms (2)

Group A: n-3 PUFA then off-treatment

EXPERIMENTAL

Participants receive n-3 PUFA supplementation (4 g/day fish oil) for 8 weeks, followed by an 8-week off-treatment period.

Dietary Supplement: n-3 PUFA (fish oil)

Group B: off-treatment then n-3 PUFA

EXPERIMENTAL

Participants undergo an 8-week off-treatment period, followed by 8 weeks of n-3 PUFA supplementation (4 g/day fish oil).

Dietary Supplement: n-3 PUFA (fish oil)

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

Group A: n-3 PUFA then off-treatment; Group B: off-treatment then n-3 PUFA

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• receiving maintenance in-center hemodialysis
• able to provide written informed consent
• clinically stable condition (no hospitalization within 4 weeks prior to baseline)

You may not qualify if:

• inability or unwillingness to provide informed consent
• known hypersensitivity or intolerance to fish oil or n-3 PUFA-containing products
• use of n-3 PUFA supplements at baseline or within the preceding 8 weeks
• pregnancy
• acute infection, hospitalization or major inflammatory condition at the time of baseline assessment
• any condition that, in the investigator's opinion, would make participation unsafe or interfere with study participation or data interpretation
• inherited lipid metabolism disorders

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Chronic Hemodialysis Unit, Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Central Study Contacts

Janosch Niknam-Saeidi, MD

CONTACT

janosch.niknamsaeidi@meduniwien.ac.at

Manfred Hecking, MD, PhD

CONTACT

manfred.hecking@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-sequence crossover: participants are randomized 1:1 to receive 8 weeks of n-3 PUFA supplementation followed by an 8-week off-treatment period (sequence A), or the reverse order (sequence B). No formal washout period is interposed; total duration is 16 weeks per participant

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

AU (1)