Clinical trial NCT06314243: The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients
Official title: The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hemodialysis Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.
timeFrame: 12 weeks
measure: To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt.
Study officials:
References: