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Completed

NCT Number: NCT06314243

The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.

The main question it aims to answer is:

• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?

Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.

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Key information

Conditions

Hemodialysis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.

Cairo, 11766, Egypt

About this study

This study aims to investigate the effects of PSO supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients via assessment of IL-6, MDA, lipid profile, and kidney function tests.

Patients & Methods:

Design: Prospective, randomized, Open label - controlled clinical trial.

Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:

  • Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
  • Group 2 (Control group): consists of 28 patients who will not receive the intervention.

Setting: Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.

Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients older than 18.
  • Patients undergoing regular HD for at least 3 months prior to enrollment.
  • Not participate in any other clinical trials.
  • Physically stable.

Exclusion criteria

  • Patients taking antioxidant supplements prior to the study's two-month time frame.
  • Patients with autoimmune, liver, cancer diseases and acquired immunodeficiency syndrome (AIDS).
  • Sensitivity to pumpkin seed oil.
  • Patients taking warfarin.
  • History of drug or alcohol abuse.
  • Pregnant or breastfeeding women and women with the possibility of getting pregnant.
  • Smokers.

Treatment and study plan

Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "

Dietary Supplement

Ronkin soft gelatin capsules, each containing 1010 mg of pumpkin seed oil (Latin name: Curcurbita pepo), standardized to contain palmitic acid (8-15%), stearic acid (3-8%), oleic acid (15-35%), linoleic acid (40-65%), and other fatty acids (≤ 2.4%)

Other names: Pepon

Primary outcomes

  1. To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.

    Time frame: 12 weeks

    To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker.

  2. To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.

    Time frame: 12 weeks

    To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker.

Secondary outcomes

  1. To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.

    Time frame: 12 weeks

    To evaluate the effect of PSO supplementation on the lipid profile, include triglyceride (TG), total cholesterol (TC), LDL, and HDL measurements.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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