{"id":"277f58f6-4d05-5360-b688-2e675f43dc61","stable_key":"27e0c1cf-7726-5164-8b15-27a631584cd0:choline-citicoline-stroke-null","predicate":"has_no_significant_effect","statement":"Global recovery was similar with citicoline and placebo: odds ratio 1.03, 95% CI 0.86–1.25, p=0.364.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"5acf2167-6a73-57db-a016-3ee6543ceb2e","mechanism_event_label":"The large stroke trial did not confirm a recovery benefit.","subject":{"id":"a3f7d46d-ea2d-5cd0-a5f4-d1091a53f99c","slug":"citicoline-trial-intervention","display_name":"Citicoline treatment in the COBRIT and ICTUS trials","entity_type_key":"chemical_species"},"object":{"id":"10faf292-f84a-5269-832a-65960e9efc62","slug":"ictus-global-recovery","display_name":"ICTUS global stroke recovery at 90 days","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"5acf2167-6a73-57db-a016-3ee6543ceb2e","stable_key":"27e0c1cf-7726-5164-8b15-27a631584cd0:choline-citicoline-stroke-null-event","event_type":"observed_intervention","label":"The large stroke trial did not confirm a recovery benefit.","description":"Global recovery was similar with citicoline and placebo: odds ratio 1.03, 95% CI 0.86–1.25, p=0.364.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"e1f22bfd-771d-5405-b2d4-ff5f4ae4d95f","slug":"cdp-choline","display_name":"CDP-choline","entity_type_key":"small_molecule"},"role":"active_molecular_identity","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"a3f7d46d-ea2d-5cd0-a5f4-d1091a53f99c","slug":"citicoline-trial-intervention","display_name":"Citicoline treatment in the COBRIT and ICTUS trials","entity_type_key":"chemical_species"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"10faf292-f84a-5269-832a-65960e9efc62","slug":"ictus-global-recovery","display_name":"ICTUS global stroke recovery at 90 days","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/choline-research/22691567.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"d70010453da46567d129e81a98e9e077bc3c787880287428ddb76023202d5648\", \"start_char\": 0, \"end_char\": 2066, \"text_sha256\": \"d70010453da46567d129e81a98e9e077bc3c787880287428ddb76023202d5648\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"ICTUS randomized masked multicenter placebo-controlled trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Citicoline 1000 mg every 12 hours, initially IV then oral for six weeks; 90-day recovery","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Trial stopped for futility. Results apply to this clinical setting, not to nutritional essentiality or all choline forms.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Choline research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"choline","display_name":"Choline","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The large stroke trial did not confirm a recovery benefit.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[choline-p22691567] Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). (2012). https://pubmed.ncbi.nlm.nih.gov/22691567/ DOI: 10.1016/s0140-6736(12)60813-7","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"2298 adults with moderate-to-severe acute ischemic stroke","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"07eb1850-295a-5067-8f8d-6425f27fae50","evidence_kind":"source_excerpt","locator":"Lines 1335-1346","start_line":1335,"end_line":1346,"excerpt":"### choline-citicoline-stroke-null\nGlobal recovery was similar with citicoline and placebo: odds ratio 1.03, 95% CI 0.86–1.25, p=0.364.\nCondition category: normal\nnutrient_topic: Choline research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The large stroke trial did not confirm a recovery benefit.\norganism: Human\ntissue_or_cell_type: 2298 adults with moderate-to-severe acute ischemic stroke\nexperimental_model: ICTUS randomized masked multicenter placebo-controlled trial\nlimitations: Trial stopped for futility. Results apply to this clinical setting, not to nutritional essentiality or all choline forms.\nexposure: Citicoline 1000 mg every 12 hours, initially IV then oral for six weeks; 90-day recovery\nevidence_span: {\"source_cache\": \"artifacts/choline-research/22691567.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"d70010453da46567d129e81a98e9e077bc3c787880287428ddb76023202d5648\", \"start_char\": 0, \"end_char\": 2066, \"text_sha256\": \"d70010453da46567d129e81a98e9e077bc3c787880287428ddb76023202d5648\"}\n[choline-p22691567] Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). 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