{"id":"2ffd30d4-fc60-540d-b32b-58ec2da2f5a4","stable_key":"1deb434a-3547-51a0-a038-87b1ce79ec38:vd-vital-fracture-total","predicate":"does-not-significantly-reduce","statement":"D3 assignment did not significantly reduce total fractures (HR0.98; 95% CI0.89–1.08; P=0.70).","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"ae2dd46c-8e78-52de-8f55-6fa97f6aabae","mechanism_event_label":"Extra D3 did not reduce this fracture endpoint in the population studied.","subject":{"id":"b162e431-b442-5400-9335-ec91f7875a4e","slug":"cholecalciferol","display_name":"Cholecalciferol","entity_type_key":"small_molecule"},"object":{"id":"1bb4cd34-b8e2-51e0-aabf-904854fb1d31","slug":"total-fracture-incidence","display_name":"Total fracture incidence","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"ae2dd46c-8e78-52de-8f55-6fa97f6aabae","stable_key":"1deb434a-3547-51a0-a038-87b1ce79ec38:vd-vital-fracture-total-event","event_type":"observed_intervention","label":"Extra D3 did not reduce this fracture endpoint in the population studied.","description":"D3 assignment did not significantly reduce total fractures (HR0.98; 95% CI0.89–1.08; P=0.70).","status":"provisional","compartment":null,"participants":[{"entity":{"id":"b162e431-b442-5400-9335-ec91f7875a4e","slug":"cholecalciferol","display_name":"Cholecalciferol","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"1bb4cd34-b8e2-51e0-aabf-904854fb1d31","slug":"total-fracture-incidence","display_name":"Total fracture incidence","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"cross_nutrient","value_text":"false","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"VITAL ancillary fracture trial; 25, 871 adults; median 5.3 years","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"D3 2000 IU/day versus placebo; randomized factorial omega 3 allocation; median 5.3 years.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Generally healthy midlife/older adults not selected for deficiency. Does not test treatment of established deficiency rickets or osteomalacia.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Vitamin D2 and D3 research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"vitamin-d","display_name":"Vitamin D2 and D3","entity_type_key":"chemical_species"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Extra D3 did not reduce this fracture endpoint in the population studied.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[leboff2022] Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults. (2022). https://pubmed.ncbi.nlm.nih.gov/35939577/ DOI: 10.1056/nejmoa2202106","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Clinical skeletal outcomes","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"d31e3df9-a60e-5e55-96b8-34990a30431a","evidence_kind":"source_excerpt","locator":"Lines 1496-1507","start_line":1496,"end_line":1507,"excerpt":"### vd-vital-fracture-total\nD3 assignment did not significantly reduce total fractures (HR0.98; 95% CI0.89–1.08; P=0.70).\nCondition category: normal\nnutrient_topic: Vitamin D2 and D3 research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Extra D3 did not reduce this fracture endpoint in the population studied.\norganism: Homo sapiens\ntissue_or_cell_type: Clinical skeletal outcomes\nexperimental_model: VITAL ancillary fracture trial; 25, 871 adults; median 5.3 years\nlimitations: Generally healthy midlife/older adults not selected for deficiency. Does not test treatment of established deficiency rickets or osteomalacia.\nexposure: D3 2000 IU/day versus placebo; randomized factorial omega 3 allocation; median 5.3 years.\ncross_nutrient: false\n[leboff2022] Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults. (2022). https://pubmed.ncbi.nlm.nih.gov/35939577/ DOI: 10.1056/nejmoa2202106","model_system":"VITAL ancillary fracture trial; 25, 871 adults; median 5.3 years","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [leboff2022] Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults. 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