The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314243
• Other study ID #: RHDIRB2020110301 REC #241
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: May 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Drug:
• Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "
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%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.	To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker.	12 weeks
Primary	To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.	To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker.	12 weeks
Secondary	To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.	To evaluate the effect of PSO supplementation on the lipid profile, include triglyceride (TG), total cholesterol (TC), LDL, and HDL measurements.	12 weeks