[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647587":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":49,"overallOfficials":28,"centralContacts":60,"locations":67,"responsibleParty":88,"collaborators":28,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":28,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":28,"enrollmentInfo":101,"targetDuration":28,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":70,"whyStopped":28,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Al-Mustansiriyah University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":28},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Serum Interleukin-6 (IL-6) level","Change in serum Interleukin-6 (IL-6) level","Baseline and 3 months",{"measure":14,"description":15,"timeFrame":12},"Serum high-sensitivity C-reactive protein (hsCRP) level","Change in high-sensitivity C-reactive protein (hsCRP) level",{"measure":17,"description":18,"timeFrame":12},"Serum soluble vascular cell adhesion molecule-1 (sVCAM-1) level","Change in soluble vascular cell adhesion molecule-1 (sVCAM-1) level",{"measure":20,"description":21,"timeFrame":12},"Serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) levels","Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) level",{"measure":23,"description":24,"timeFrame":12},"Serum malondialdehyde (MDA) level","Change in malondialdehyde (MDA) level",{"measure":26,"description":27,"timeFrame":12},"Serum superoxide dismutase (SOD) activity","Change in superoxide dismutase (SOD) activity",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","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.\n\nNo 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.\n\nThis study addresses that gap by evaluating the effect of 1000 mg\u002Fday 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.",[37,44],{"label":38,"type":39,"description":40,"interventionNames":41},"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.",[42,43],"Dietary Supplement: Pumpkin Seed Oil 1000 mg","Procedure: Standard hemodialysis care",{"label":45,"type":46,"description":47,"interventionNames":48},"Usual Care (Control)","ACTIVE_COMPARATOR","Participants =continue routine hemodialysis usual care only, without pumpkin seed oil or placebo.",[43],[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":28},"DIETARY_SUPPLEMENT","Pumpkin Seed Oil 1000 mg","Pumpkin seed oil, 1000 mg, oral capsule\u002Ftablet, once daily (taken on dialysis days after the dialysis session), for 3 months, added to the standard hemodialysis care protocol.",[38],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":28},"PROCEDURE","Standard hemodialysis care","Standard hemodialysis care per center protocol, with no additional study supplement.",[38,45],[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"mohammed mahmood M mohammed, professor","CONTACT","07816871131","+964","pharm.drmhdclinical@uomustansiriyah.edu.iq",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Al-Karama Teaching Hospital, Hemodialysis Center","RECRUITING","Baghdad","Karkh","10064","Iraq","IQ",{"type":77,"coordinates":78},"Point",[79,80],44.40088,33.34058,{"lat":80,"lon":79},[83],{"name":84,"role":63,"phone":85,"phoneExt":86,"email":87},"Rana Bahaa Mohammed, MSc","7705846087","00964","rana_clinicalphd@uomustansiriyah.edu.iq",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Mohammed Mahmood Mohammed","Principle Investigator","100647587","pumpkin-seed-oil-as-a-nutraceutical-for-hemodialysis-patients-100647587",false,"NCT07710183","Pumpkin Seed Oil as a Nutraceutical for Hemodialysis Patients","Potential Role of Pumpkin Seed Oil as a Nutraceutical on the Clinical and Biochemical Outcomes in Hemodialysis Patients","Inclusion Criteria:\n\n* End-stage renal disease (ESRD) on hemodialysis for more than 6 months, on a constant dialysis program.\n* Hemodynamically stable (no recent hospitalization for infections, cardiovascular events, or major surgery within the past 3 months).\n* No active acute infections.\n* Serum albumin ≥ 3.0 g\u002FdL.\n\nExclusion Criteria:\n\n* Regular intake of dietary supplements (e.g., omega-3, antioxidants) for at least one month prior to enrollment.\n* Autoimmune disease, liver disease, cancer, or acquired immunodeficiency syndrome (AIDS).\n* Known sensitivity\u002Fallergy to pumpkin seed oil.\n* Current use of lipid-lowering agents.\n* Diabetes mellitus.\n* Current use of anticoagulants (warfarin, direct oral anticoagulants).\n* Current use of immunosuppressants, corticosteroids, or anti-inflammatory drugs.\n* Pregnant or breastfeeding women.\n* Residual kidney function (urine output \\> 200 mL\u002Fday).","ALL","18 Years",{"count":102,"type":103},100,"ESTIMATED","INTERVENTIONAL",[106],"NA","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\u002Fday 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",[109,110,111,112],"End Stage Renal Disease","Chronic Kidney Disease Requiring Chronic Dialysis","Inflammation","Oxidative Stress",[114,115,116,117,118,119,120,121],"Pumpkin seed oil","Hemodialysis","IL-6","hsCRP","sVCAM-1","Malondialdehyde","Superoxide dismutase","Lipid profile","2026-07-13",{"date":124,"type":125},"2026-07-17","ACTUAL",{"date":127,"type":103},"2026-07-20",{"date":129,"type":103},"2027-04-01",{"name":5,"class":6},1]