{"id":"bace554a-4a14-576d-b43c-95f0fa47850a","stable_key":"1deb434a-3547-51a0-a038-87b1ce79ec38:vd-sanders-fractures","predicate":"increases-under-annual-bolus-regimen","statement":"There were 171 versus 135 fractures; fracture rate ratio 1.26 (95% CI1.00–1.59; P=0.047) for annual D3 versus placebo.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"positive","is_public":true,"mechanism_event_id":"7601f4e6-5f99-572e-90d7-515859dc1418","mechanism_event_label":"Fractures were also more frequent under that specific regimen.","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":"7601f4e6-5f99-572e-90d7-515859dc1418","stable_key":"1deb434a-3547-51a0-a038-87b1ce79ec38:vd-sanders-fractures-event","event_type":"observed_intervention","label":"Fractures were also more frequent under that specific regimen.","description":"There were 171 versus 135 fractures; fracture rate ratio 1.26 (95% CI1.00–1.59; P=0.047) for annual D3 versus placebo.","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":"2256 community-dwelling women aged≥ 70; annual-bolus randomized placebo-controlled trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"500, 000 IU oral D3 each autumn/winter for 3–5 years.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Annual very large bolus in older women; does not demonstrate that all D3 regimens raise risk.","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":"Fractures were also more frequent under that specific regimen.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[sanders2010] Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. (2010). https://pubmed.ncbi.nlm.nih.gov/20460620/ DOI: 10.1001/jama.2010.594","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":"af2b6fcf-c75a-58c1-9f68-8d0133622890","evidence_kind":"source_excerpt","locator":"Lines 1587-1598","start_line":1587,"end_line":1598,"excerpt":"### vd-sanders-fractures\nThere were 171 versus 135 fractures; fracture rate ratio 1.26 (95% CI1.00–1.59; P=0.047) for annual D3 versus placebo.\nCondition category: normal\nnutrient_topic: Vitamin D2 and D3 research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Fractures were also more frequent under that specific regimen.\norganism: Homo sapiens\ntissue_or_cell_type: Clinical skeletal outcomes\nexperimental_model: 2256 community-dwelling women aged≥ 70; annual-bolus randomized placebo-controlled trial\nlimitations: Annual very large bolus in older women; does not demonstrate that all D3 regimens raise risk.\nexposure: 500, 000 IU oral D3 each autumn/winter for 3–5 years.\ncross_nutrient: false\n[sanders2010] Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. 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