{"id":"calcifediol-oral-product","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypercalcemia"},{"rate":null,"effect":"Hyperphosphatemia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Calcifediol (1,25-dihydroxyvitamin D3) is a potent active form of vitamin D that acts as a ligand for the vitamin D receptor (VDR), a nuclear receptor that regulates gene expression involved in calcium absorption, phosphate metabolism, and immune cell differentiation. By activating VDR signaling, calcifediol increases intestinal calcium absorption and helps maintain mineral homeostasis, while also modulating T-cell and B-cell function through immune regulatory pathways.","oneSentence":"Calcifediol is an active vitamin D metabolite that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis and modulate immune function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:29:31.943Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Secondary hyperparathyroidism in patients with chronic kidney disease"},{"name":"Hypocalcemia in patients with hypoparathyroidism"}]},"trialDetails":[{"nctId":"NCT07269223","phase":"NA","title":"Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients","status":"RECRUITING","sponsor":"University of Veterinary and Animal Sciences, Lahore - Pakistan","startDate":"2025-09-02","conditions":"Ulcerative Colitis (UC)","enrollment":60},{"nctId":"NCT05543928","phase":"PHASE3","title":"Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism","status":"TERMINATED","sponsor":"OPKO Health, Inc.","startDate":"2023-01-31","conditions":"Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency","enrollment":2},{"nctId":"NCT04551911","phase":"PHASE2","title":"Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19","status":"COMPLETED","sponsor":"OPKO Health, Inc.","startDate":"2020-11-02","conditions":"COVID-19, Coronavirus, SARS-CoV2 Infection","enrollment":171},{"nctId":"NCT03588884","phase":"PHASE4","title":"Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency","status":"COMPLETED","sponsor":"OPKO Health, Inc.","startDate":"2018-06-08","conditions":"Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3","enrollment":69},{"nctId":"NCT04591847","phase":"PHASE3","title":"Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy","status":"COMPLETED","sponsor":"Department of Medical Services Ministry of Public Health of Thailand","startDate":"2020-10-19","conditions":"Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy","enrollment":60},{"nctId":"NCT01012414","phase":"PHASE3","title":"Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease","status":"TERMINATED","sponsor":"Thomas Jefferson University","startDate":"2010-01","conditions":"Coronary Artery Disease, Chronic Kidney Disease, Hypovitaminosis D","enrollment":10}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Calcifediol Oral Product","genericName":"Calcifediol Oral Product","companyName":"OPKO Health, Inc.","companyId":"opko-health-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Calcifediol is an active vitamin D metabolite that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis and modulate immune function. Used for Secondary hyperparathyroidism in patients with chronic kidney disease, Hypocalcemia in patients with hypoparathyroidism.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}