End Stage Renal DiseaseNCT07710183
Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients
A study testing Pumpkin Seed Oil 1000 mg and Standard hemodialysis care in people with End Stage Renal Disease and Chronic Kidney Disease Requiring Chronic Dialysis, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease Requiring Chronic Dialysis, Inflammation
- What is being tested?
- Pumpkin Seed Oil 1000 mg and Standard hemodialysis care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 20 Jul 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease (ESRD) on hemodialysis for more than 6 months, on a constant dialysis program.
- Hemodynamically stable (no recent hospitalization for infections, cardiovascular events, or major surgery within the past 3 months).
- No active acute infections.
- Serum albumin ≥ 3.0 g/dL.
Who cannot join
- Regular intake of dietary supplements (e.g., omega-3, antioxidants) for at least one month prior to enrollment.
- Autoimmune disease, liver disease, cancer, or acquired immunodeficiency syndrome (AIDS).
- Known sensitivity/allergy to pumpkin seed oil.
- Current use of lipid-lowering agents.
- Diabetes mellitus.
- Current use of anticoagulants (warfarin, direct oral anticoagulants).
Show all 9Show fewer
- Current use of immunosuppressants, corticosteroids, or anti-inflammatory drugs.
- Pregnant or breastfeeding women.
- Residual kidney function (urine output > 200 mL/day).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mohammed mahmood M mohammed, professor contact
Iraq1 site, 1 recruiting
- Recruiting
Al-Karama Teaching Hospital, Hemodialysis Center
Baghdad, Karkh, 10064
Rana Bahaa Mohammed, MSc, 7705846087 ext. 00964, rana_clinicalphd@uomustansiriyah.edu.iq
About this study
Official title: Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients
Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq
Read the detailed description
Chronic systemic inflammation is a cornerstone of hemodialysis pathophysiology, driven by uremic toxin retention, oxidative stress, endotoxemia, and repeated exposure to bioincompatible dialysis membranes, which activate NF-κB and STAT signaling and sustain elevated IL-6 and CRP. These biomarkers are independent predictors of cardiovascular and all-cause mortality, and contribute to the malnutrition-inflammation complex syndrome (MICS) that affects a substantial proportion of dialysis patients. sVCAM-1 acts as a mechanistic bridge between the uremic milieu and accelerated atherosclerosis, mediating monocyte adhesion to the arterial intima and serving as an independent predictor of cardiovascular mortality in this population.
No pharmacological agent is currently routinely or universally prescribed to specifically target inflammation in hemodialysis patients; existing options (e.g., anti-IL-6 agents, statins, pentoxifylline, nutraceuticals such as curcumin, omega-3 fatty acids, and vitamin E) show variable biomarker reductions but have not been widely incorporated into standard practice. Pumpkin seed oil has shown anti-inflammatory and antioxidant effects in animal and in vitro studies, including suppression of IL-1β, IL-6, TNF-α, and COX-2, with effects in some models comparable to NSAIDs. Vitamin E, a major constituent of pumpkin seed oil, has separately been shown to reduce circulating sVCAM-1 in hemodialysis patients via suppression of oxidative stress. However, to the investigators' knowledge, no prior human study has directly examined the impact of pumpkin seed oil on IL-6 and CRP in hemodialysis patients, and no study has investigated its effect on sVCAM-1 specifically in this population.
This study addresses that gap by evaluating the effect of 1000 mg/day oral pumpkin seed oil for 3 months, in addition to usual hemodialysis care, on inflammatory (IL-6, hsCRP, sVCAM-1), oxidative stress (MDA, SOD), and lipid biomarkers, compared with a usual-care control group, in patients with ESRD on maintenance hemodialysis at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq.
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease Requiring Chronic Dialysis, Inflammation, Oxidative Stress
- Being tested
- Pumpkin Seed Oil 1000 mg, Standard hemodialysis care
- Keywords
- Pumpkin seed oil, Hemodialysis, IL-6, hsCRP, sVCAM-1, Malondialdehyde, Superoxide dismutase, Lipid profile
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin Seed Oil 1000 mgDietary supplement
Pumpkin seed oil, 1000 mg, oral capsule/tablet, once daily (taken on dialysis days after the dialysis session), for 3 months, added to the standard hemodialysis care protocol.
Standard hemodialysis careProcedure or surgery
Standard hemodialysis care per center protocol, with no additional study supplement.
| Study group | Role | What they receive |
|---|---|---|
| Pumpkin Seed Oil + Usual Care | Experimental | Participants receive pumpkin seed oil 1000 mg orally once daily for 3 consecutive months, in addition to their standard hemodialysis usual care. Receives: Dietary Supplement: Pumpkin Seed Oil 1000 mg; Procedure: Standard hemodialysis care |
| Usual Care (Control) | Active comparator | Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo. Receives: Procedure: Standard hemodialysis care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin-6 (IL-6) level
Change in serum Interleukin-6 (IL-6) level
Measured: Baseline and 3 months
Serum high-sensitivity C-reactive protein (hsCRP) level
Change in high-sensitivity C-reactive protein (hsCRP) level
Measured: Baseline and 3 months
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Measured: Baseline and 3 months
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
Measured: Baseline and 3 months
Serum malondialdehyde (MDA) level
Change in malondialdehyde (MDA) level
Measured: Baseline and 3 months
Serum superoxide dismutase (SOD) activity
Change in superoxide dismutase (SOD) activity
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mahmood Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710183
- Sponsor's protocol ID
- SOP117
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07710183
- Acronym / sponsor ID
- SOP117
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease Requiring Chronic Dialysis, Inflammation, Oxidative Stress
- Keywords
- Pumpkin seed oil, Hemodialysis, IL-6, hsCRP, sVCAM-1, Malondialdehyde, Superoxide dismutase, Lipid profile
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with end-stage renal disease (ESRD) on maintenance hemodialysis experience chronic systemic inflammation, oxidative stress, and dyslipidemia, which together drive much of the excess cardiovascular morbidity and mortality seen in this population. Pumpkin seed oil is a nutraceutical rich in polyunsaturated fatty acids, phytosterols,and tocopherols, with documented antioxidant, anti-inflammatory, and antihyperlipidemic properties in preclinical and limited clinical studies. This study investigates the potential role of pumpkin seed oil as a nutraceutical on the clinical and biochemical outcomes of hemodialysis patients. It is a randomized, open-label, prospective interventional study in which daily oral supplementation with pumpkin seed oil (1000 mg once daily) for 3 months is evaluated against usual care. Eighty-five participants will be assigned to either an intervention group (n=45, pumpkin seed oil 1000 mg/day plus usual care) or a control group (n=40, usual care only). The biochemical outcomes assessed are changes in serum interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), lipid profile, malondialdehyde (MDA), and superoxide dismutase (SOD) from baseline to the end of the 3-month follow-up period. The study is being conducted at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq
Detailed description
Chronic systemic inflammation is a cornerstone of hemodialysis pathophysiology, driven by uremic toxin retention, oxidative stress, endotoxemia, and repeated exposure to bioincompatible dialysis membranes, which activate NF-κB and STAT signaling and sustain elevated IL-6 and CRP. These biomarkers are independent predictors of cardiovascular and all-cause mortality, and contribute to the malnutrition-inflammation complex syndrome (MICS) that affects a substantial proportion of dialysis patients. sVCAM-1 acts as a mechanistic bridge between the uremic milieu and accelerated atherosclerosis, mediating monocyte adhesion to the arterial intima and serving as an independent predictor of cardiovascular mortality in this population.
No pharmacological agent is currently routinely or universally prescribed to specifically target inflammation in hemodialysis patients; existing options (e.g., anti-IL-6 agents, statins, pentoxifylline, nutraceuticals such as curcumin, omega-3 fatty acids, and vitamin E) show variable biomarker reductions but have not been widely incorporated into standard practice. Pumpkin seed oil has shown anti-inflammatory and antioxidant effects in animal and in vitro studies, including suppression of IL-1β, IL-6, TNF-α, and COX-2, with effects in some models comparable to NSAIDs. Vitamin E, a major constituent of pumpkin seed oil, has separately been shown to reduce circulating sVCAM-1 in hemodialysis patients via suppression of oxidative stress. However, to the investigators' knowledge, no prior human study has directly examined the impact of pumpkin seed oil on IL-6 and CRP in hemodialysis patients, and no study has investigated its effect on sVCAM-1 specifically in this population.
This study addresses that gap by evaluating the effect of 1000 mg/day oral pumpkin seed oil for 3 months, in addition to usual hemodialysis care, on inflammatory (IL-6, hsCRP, sVCAM-1), oxidative stress (MDA, SOD), and lipid biomarkers, compared with a usual-care control group, in patients with ESRD on maintenance hemodialysis at the Hemodialysis Center, Al-Karama Teaching Hospital, Iraq.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumpkin Seed Oil + Usual Care | Experimental | Dietary Supplement: Pumpkin Seed Oil 1000 mg, Procedure: Standard hemodialysis careParticipants receive pumpkin seed oil 1000 mg orally once daily for 3 consecutive months, in addition to their standard hemodialysis usual care. |
| Usual Care (Control) | Active comparator | Procedure: Standard hemodialysis careParticipants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End-stage renal disease (ESRD) on hemodialysis for more than 6 months, on a constant dialysis program.
- Hemodynamically stable (no recent hospitalization for infections, cardiovascular events, or major surgery within the past 3 months).
- No active acute infections.
- Serum albumin ≥ 3.0 g/dL.
Key exclusion criteria (9 listed)
- Regular intake of dietary supplements (e.g., omega-3, antioxidants) for at least one month prior to enrollment.
- Autoimmune disease, liver disease, cancer, or acquired immunodeficiency syndrome (AIDS).
- Known sensitivity/allergy to pumpkin seed oil.
- Current use of lipid-lowering agents.
- Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pumpkin Seed Oil 1000 mgPumpkin seed oil, 1000 mg, oral capsule/tablet, once daily (taken on dialysis days after the dialysis session), for 3 months, added to the standard hemodialysis care protocol. | Dietary supplement | Pumpkin Seed Oil + Usual Care |
| Standard hemodialysis careStandard hemodialysis care per center protocol, with no additional study supplement. | Procedure or surgery | Pumpkin Seed Oil + Usual Care, Usual Care (Control) |
Primary outcome
Serum Interleukin-6 (IL-6) level
Time frame: Baseline and 3 months
Change in serum Interleukin-6 (IL-6) level
Serum high-sensitivity C-reactive protein (hsCRP) level
Time frame: Baseline and 3 months
Change in high-sensitivity C-reactive protein (hsCRP) level
Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Time frame: Baseline and 3 months
Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level
Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels
Time frame: Baseline and 3 months
Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level
Serum malondialdehyde (MDA) level
Time frame: Baseline and 3 months
Change in malondialdehyde (MDA) level
Serum superoxide dismutase (SOD) activity
Time frame: Baseline and 3 months
Change in superoxide dismutase (SOD) activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohammed mahmood M mohammed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumpkin Seed Oil 1000 mg and Standard hemodialysis care in people with End Stage Renal Disease and Chronic Kidney Disease Requiring Chronic Dialysis, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohammed mahmood M mohammed, professor (07816871131 ext. +964, pharm.drmhdclinical@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin-6 (IL-6) level (time frame: Baseline and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.