The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

NCT06314243 | Completed DMC

• 1 other identifier: RHDIRB2020110301 REC #241
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  12 weeks

Study Arms (2)

Pumpkin Seed Oil group

EXPERIMENTAL

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. "

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

Control group

NO INTERVENTION

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

Interventions

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%)

Also known as: Pepon

Pumpkin Seed Oil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, 11766, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Clinical Pharmacy Department, Faculty of pharmacy, Ain Shams University

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: September 4, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 10, 2025
• Last Updated: August 6, 2025

Record last verified: 2024-07

Locations

EG (1)