Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients
Recruiting · NCT07710183 · Interventional (participants receive a specific treatment) · Lead sponsor: Al-Mustansiriyah University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq
Who can take part
Inclusion criteria
- End-stage renal disease (ESRD) on hemodialysis for more than 6 months, on a constant dialysis program.
- Hemodynamically stable (no recent hospitalization for infections, cardiovascular events, or major surgery within the past 3 months).
- No active acute infections.
- Serum albumin ≥ 3.0 g/dL.
Exclusion criteria
- Regular intake of dietary supplements (e.g., omega-3, antioxidants) for at least one month prior to enrollment.
- Autoimmune disease, liver disease, cancer, or acquired immunodeficiency syndrome (AIDS).
- Known sensitivity/allergy to pumpkin seed oil.
- Current use of lipid-lowering agents.
- Diabetes mellitus.
- Current use of anticoagulants (warfarin, direct oral anticoagulants).
- Current use of immunosuppressants, corticosteroids, or anti-inflammatory drugs.
- Pregnant or breastfeeding women.
- Residual kidney function (urine output \> 200 mL/day).
Where it is running
1 location listed.
- Al-Karama Teaching Hospital, Hemodialysis Center - Baghdad, Karkh, Iraq