The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

Ain Shams University

Status: Completed

Conditions: Hemodialysis Patients

Treatments: Dietary Supplement: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "

Study type: Interventional

Funder types: Other

Identifiers

NCT06314243

RHDIRB2020110301 REC #241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Pumpkin Seed Oil group

Experimental group

Description:

Group 1 (Pumpkin Seed Oil group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "

Treatment:

Dietary Supplement: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "

Control group

No Intervention group

Description:

Group 2 (Control group): consists of 28 patients who will not receive the intervention.