[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594570":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":43,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":43,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":43,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":65,"whyStopped":43,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"General Committee of Teaching Hospitals and Institutes, Egypt","OTHER_GOV",[8,14,19,24,28,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Elan in Patients Undergoing Sleeve Gastrectomy","ACTIVE_COMPARATOR","Patients undergoing sleeve gastrectomy and administrating Elan Specialized Bariatric Supplements (Elan Believe)",[13],"Dietary Supplement: Elan Believe",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy","Patients undergoing sleeve gastrectomy and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals)",[18],"Dietary Supplement: Standard Multivitamins",{"label":20,"type":10,"description":21,"interventionNames":22},"Elan in Patients Undergoing Roux-en-Y Gastric Bypass","Patients undergoing Roux-en-Y Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Compass)",[23],"Dietary Supplement: Elan Compass",{"label":25,"type":10,"description":26,"interventionNames":27},"Standard Multivitamins in Patients Undergoing Roux-en-Y Gastric Bypass","Patients undergoing Roux-en-Y Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals)",[18],{"label":29,"type":10,"description":30,"interventionNames":31},"Elan in Patients Undergoing One-Anastomosis Gastric Bypass","Patients undergoing One-Anastomosis Gastric Bypass and administrating Elan Specialized Bariatric Supplements (Elan Supreme)",[32],"Dietary Supplement: Elan Supreme",{"label":34,"type":10,"description":35,"interventionNames":36},"Standard Multivitamins in Patients Undergoing One-Anastomosis Gastric Bypass","Patients undergoing One-Anastomosis Gastric Bypass and administrating Standard Multivitamins (over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals)",[18],[38,44,48,52],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DIETARY_SUPPLEMENT","Elan Believe","Elan Believe is formulated specifically for patients undergoing SG and contains 18 mg of elemental zinc.",[9],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Elan Compass","Elan Compass is tailored for RYGB and contains 24 mg of zinc.",[20],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"Elan Supreme","Designed for OAGB, provides 36 mg of zinc.",[29],{"type":39,"name":53,"description":54,"armGroupLabels":55,"otherNames":43},"Standard Multivitamins","Over-the-counter multivitamin containing 100% of the recommended daily allowance (RDA) for essential vitamins and minerals. Unlike the specialized formulations, the standard multivitamin is not designed to accommodate the altered gastrointestinal absorption characteristics of post-MBS patients.",[34,25,15],[57],{"name":58,"role":59,"phone":60,"phoneExt":43,"email":61},"Mohamed Ashour, Ph.D. (Professor)","CONTACT","+201002600970","mohamed.ashour@alexu.edu.eg",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"The surgical department of Medical Research Institute Hospital, Alexandria University","RECRUITING","Alexandria","Alexandria Governorate","21531","Egypt","EG",{"type":72,"coordinates":73},"Point",[74,75],29.91582,31.20176,{"lat":75,"lon":74},[78],{"name":58,"role":59,"phone":60,"phoneExt":43,"email":61},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Mohamed Hany Ashour","Professor of General surgery","100594570","phase-4-trial-comparing-elan-specialized-bariatric-supplements-with-standard-multivitamins-in-patients-undergoing-bariatric-procedures-100594570",false,"NCT07021170","Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Bariatric Procedures","A Double-Blinded Randomized Controlled Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, and One-Anastomosis Gastric Bypass","Inclusion Criteria:\n\nEligible participants must be adults:\n\n* Aged 18 to 65 years\n* Capable of providing informed consent\n* Willing to comply with study procedures and follow-up visits over 12 months.\n* Candidates must have no prior history of MBS or gastrointestinal surgery and must be scheduled for one of the three aforementioned primary procedures.\n* Both male and female patients will be considered, and no restrictions will be placed based on ethnicity or socioeconomic status.\n\nExclusion Criteria:\n\nExclusion criteria include:\n\n* The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency.\n* Additional exclusion criteria include pregnancy or lactation at the time of enrollment\n* Plans for pregnancy within the study period\n* Active malignancy\n* Any use of investigational drugs or supplements within the past 30 days.\n* Patients undergoing revisional bariatric surgery or conversion procedures will also be excluded.",true,"ALL","18 Years","65 Years",{"count":95,"type":96},624,"ESTIMATED","INTERVENTIONAL",[99],"PHASE4","Obesity has escalated to pandemic levels, impacting over 650 million adults globally and significantly contributing to the burden of non-communicable diseases such as type 2 diabetes, cardiovascular disease, obstructive sleep apnea, non-alcoholic fatty liver disease, and infertility. The chronic, multifactorial nature of obesity presents substantial challenges for long-term management, as lifestyle modifications and pharmacotherapy often yield limited and transient success. In this context, Metabolic and bariatric surgery (MBS) has emerged as the most effective and enduring treatment for obesity, offering significant weight loss and marked improvement or remission of obesity-related comorbidities.\n\nThe most prevalent MBS procedures include sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). While these interventions offer considerable metabolic advantages, they inherently cause significant modifications to gastrointestinal anatomy and physiology, which can predispose patients to long-term micronutrient deficiencies. These deficiencies can stem from reduced dietary intake, altered gastric acid secretion, decreased intrinsic factor production, and the bypassing of critical absorptive sites in the gastrointestinal tract. Commonly affected nutrients encompass iron, vitamin B12, Vitamin B6, folate, vitamin D, calcium, and zinc. If not effectively managed, these nutrient deficiencies can lead to anemia, secondary hyperparathyroidism, osteopenia, neurological complications, immune dysfunction, and impaired postoperative recovery.\n\nPopulation-based recommended dietary allowances (RDAs) and tolerable upper intake levels (ULs) tend to underestimate the nutritional requirements for postoperative patients, as they are derived from healthy cohorts. Many standard formulations may fall short due to inadequate dosages, non-bioavailable forms, or poor tolerability, which can significantly impact patient adherence to supplementation regimens. Over-the-counter multivitamins, such as Centrum®, are designed for the general population and often lack the dosing, bioavailability, or elemental forms required for post-MBS physiology, particularly following bypass procedures.\n\nThe American Society for Metabolic and Bariatric Surgery (ASMBS) recommends 8-22 mg of elemental zinc per day, depending on the procedure, and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the World Gastroenterology Organization (WGO) recommend up to 30 mg\u002Fday for OAGB patients. These values are below the national upper limit in Egypt, which is 25 mg\u002Fday.\n\nMoreover, there is evidence indicating a discrepancy in nutrient deficiencies among different bariatric surgery patients; for instance, OAGB patients exhibit a greater prevalence of iron and zinc deficiencies compared to those undergoing RYGB or SG, thereby necessitating proportionally higher supplementation tailored to their specific needs.",[102],"Vitamin Deficiencies",[104,53,105,106,107],"Elan Specialized Bariatric Supplements","Sleeve Gastrectomy","Roux-en-Y Gastric Bypass","One-Anastomosis Gastric Bypass","2025-09-10",{"date":110,"type":111},"2025-09-16","ACTUAL",{"date":113,"type":111},"2025-06-15",{"date":115,"type":96},"2026-06",{"name":5,"class":6},1]