[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fracture-tibia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fracture-tibia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100615995","oral-supplementation-with-a-formulation-based-on-cetylated-fatty-acids-for-post-fracture-long-bone-healing-100615995",false,"NCT07299851","Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing","Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization","CETIULTRA-BONE","Inclusion Criteria:\n\n* Between 18 and 85 years old\n* Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization\n* Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)\n* Presence intramedullary nail\n* Weight bearing as tolerated after surgery\n* Having signed an informed consent, understand study procedures and ability to follow them\n* Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D\n\nExclusion Criteria:\n\n* Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)\n* BMI \\> 30\n* Open fracture\n* Intra articular fracture\n* Metaphyseal fracture\n* Polytrauma patient (injury severity score: ISS \\>= 16)\n* More than one lower limb long bone fracture\n* Bridging plate\n* Fracture treated conservatively with plaster\n* Presence of active infection (body temperature ≥ 38°C or other symptoms)\n* Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)\n* Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease\u002Fsyndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)\n* Participants with known bone disease which would negatively impact on the bone healing process\n* Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy\n* Diabetic participants\n* Daily smoker participants (cigarette or vaping containing nicotine)\n* Participants under cortisone intake\n* Participants under rheumatic medications intake\n* Allergy or adverse effect of food supplement composition\n* Unwilling or unable to take study medication\n* Chronic drug or alcohol abuse\n* Pregnant or breastfeeding at the time of enrolment\n* Any other investigational treatment or food supplement within 3 months.","ALL","18 Years","85 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.",[28,29],"Fracture Femur","Fracture Tibia","RECRUITING","2025-12-17",{"date":33,"type":34},"2025-12-23","ACTUAL",{"date":36,"type":34},"2025-10-01",{"date":38,"type":22},"2026-06",{"name":40,"class":41},"Pharmanutra S.p.a.","INDUSTRY",6]