Hemodialysis Patients
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPumpkin 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%)
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients. | 12 weeks | To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker. |
| To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients. | 12 weeks | To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients. | 12 weeks | To evaluate the effect of PSO supplementation on the lipid profile, include triglyceride (TG), total cholesterol (TC), LDL, and HDL measurements. |
Countries
Egypt
Outcome results
None listed