Fish Oil and HDL Function in Patients on Maintenance Hemodialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
n-3 PUFA (fish oil)
Dietary supplement4g/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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group A: n-3 PUFA then off-treatmentExperimental treatment 1 intervention
Group B: Group B: off-treatment then n-3 PUFAExperimental treatment 1 intervention
Trial outcomes
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 (%).
Time frame
Weeks 1, 8, and 16Secondary outcomes
1
Serum Amyloid A (SAA)
Serum amyloid A concentration in serum, obtained from routine clinical laboratory measurement and reported in mg/L.
Time frame
Weeks 1, 8, and 162
Biologically Effective HDL
Biologically effective HDL, calculated from concomitantly measured HDL cholesterol and serum amyloid A concentrations and reported in mg/dL.
Time frame
Weeks 1, 8, and 16Sponsors and contacts
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Source ClinicalTrials.gov
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