{"id":"high-dose-of-fat-soluble-vitamin","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypervitaminosis A (toxicity at high doses)"},{"rate":null,"effect":"Hypercalcemia (from excess vitamin D)"},{"rate":null,"effect":"Gastrointestinal upset"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fat-soluble vitamins are essential micronutrients that require dietary fat for absorption and are stored in adipose tissue and the liver. At high doses, they can modulate gene expression, enhance antioxidant defenses, regulate calcium homeostasis, and support immune and metabolic function. The therapeutic rationale in a Phase 3 trial likely targets deficiency states or conditions where supplementation may improve clinical outcomes.","oneSentence":"High-dose fat-soluble vitamins (A, D, E, K) are absorbed in the intestine and distributed to tissues where they function as cofactors and signaling molecules to support cellular health and physiological function.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:47:51.030Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fat-soluble vitamin deficiency (specific indication not detailed in available information)"}]},"trialDetails":[{"nctId":"NCT05578404","phase":"PHASE2","title":"High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease","status":"COMPLETED","sponsor":"Tanta University","startDate":"2022-10-20","conditions":"Non-Alcoholic Fatty Liver Disease","enrollment":100},{"nctId":"NCT03734744","phase":"NA","title":"PK/PD of Vitamin D3 in Adults With CF","status":"TERMINATED","sponsor":"University of Southern California","startDate":"2019-06-17","conditions":"Vitamin D Deficiency, Cystic Fibrosis","enrollment":6},{"nctId":"NCT03614403","phase":"NA","title":"The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy","status":"COMPLETED","sponsor":"Shahid Beheshti University","startDate":"2017-07-30","conditions":"Brain Neoplasms","enrollment":60},{"nctId":"NCT03876704","phase":"PHASE3","title":"Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2019-01-29","conditions":"Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency","enrollment":120},{"nctId":"NCT03248544","phase":"NA","title":"Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery","status":"COMPLETED","sponsor":"Shahid Beheshti University","startDate":"2017-07-06","conditions":"Brain Neoplasms","enrollment":60},{"nctId":"NCT00698256","phase":"NA","title":"Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins","status":"COMPLETED","sponsor":"Marjukka Kolehmainen","startDate":"2008-02","conditions":"Hypercholesterolemia","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":31,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"High dose of fat-Soluble Vitamin","genericName":"High dose of fat-Soluble Vitamin","companyName":"First Affiliated Hospital Xi'an Jiaotong University","companyId":"first-affiliated-hospital-xi-an-jiaotong-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"High-dose fat-soluble vitamins (A, D, E, K) are absorbed in the intestine and distributed to tissues where they function as cofactors and signaling molecules to support cellular health and physiological function. Used for Fat-soluble vitamin deficiency (specific indication not detailed in available information).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}