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Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Iraq
Al-Karama Teaching Hospital, Hemodialysis Center
RECRUITING
Baghdad
Contact Information
Primary
mohammed mahmood M mohammed, professor
pharm.drmhdclinical@uomustansiriyah.edu.iq
07816871131
Time Frame
Start Date: 2026-07-20
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 100
Treatments
Experimental: Pumpkin Seed Oil + Usual Care
Participants receive pumpkin seed oil 1000 mg orally once daily for 3 consecutive months, in addition to their standard hemodialysis usual care.
Active_comparator: Usual Care (Control)
Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.
Related Therapeutic Areas
Sponsors
Leads: Al-Mustansiriyah University

This content was sourced from clinicaltrials.gov