{"id":"c3abd73b-0ff8-5403-9020-3f3971bf4d7a","stable_key":"6d38d43e-01e4-5641-93be-65654271e242:zn-clin-diarrhea-dose-efficacy","predicate":"lower_doses_met_noninferiority_for","statement":"Diarrhea beyond five days occurred in 6.5%, 7.7% and 7.2% of the 20, 10 and 5 mg groups. The lower doses met the four-percentage-point noninferiority margin; stool counts also met the two-stool margin.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"e131a02c-c10a-5828-b61c-40fdcb2b8de3","mechanism_event_label":"The tested lower doses preserved trial-defined efficacy.","subject":{"id":"9f823444-e2dd-5e16-9440-1bf2f62e8bdf","slug":"zinc-sulfate","display_name":"Zinc sulfate","entity_type_key":"chemical_species"},"object":{"id":"65441385-8efe-5499-8a03-1b4d9c0ffaa4","slug":"child-diarrheal-illness-days","display_name":"Child diarrheal illness days","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"e131a02c-c10a-5828-b61c-40fdcb2b8de3","stable_key":"6d38d43e-01e4-5641-93be-65654271e242:zn-clin-diarrhea-dose-efficacy-event","event_type":"observed_intervention","label":"The tested lower doses preserved trial-defined efficacy.","description":"Diarrhea beyond five days occurred in 6.5%, 7.7% and 7.2% of the 20, 10 and 5 mg groups. The lower doses met the four-percentage-point noninferiority margin; stool counts also met the two-stool margin.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"18261907-3c44-5276-80b4-7344b1115fb9","slug":"child-total-loose-watery-stools","display_name":"Total loose or watery stools after enrollment","entity_type_key":"cellular_process"},"role":"co_primary_endpoint","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"9f823444-e2dd-5e16-9440-1bf2f62e8bdf","slug":"zinc-sulfate","display_name":"Zinc sulfate","entity_type_key":"chemical_species"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"65441385-8efe-5499-8a03-1b4d9c0ffaa4","slug":"child-diarrheal-illness-days","display_name":"Child diarrheal illness days","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"cross_nutrient","value_text":"Total loose or watery stools after enrollment (co_primary_endpoint)","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_location","value_text":"Indexed primary abstract; accessible manuscript Methods and Results also inspected.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/zinc-clinical-sources/dhingra2020.abstract.txt\", \"locator\": \"Primary indexed abstract; complete local file\", \"file_sha256\": \"48deafc698125c49384f5678bf65f3af2a4fc3359510f29a9a94a6b4991ee03e\", \"utf8_bytes\": 2238}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Double-blind randomized multicenter noninferiority trial in 4500 children aged 6–59 months in India and Tanzania","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"5, 10 or 20 mg zinc/day using zinc sulfate for 14 days.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Active-dose comparisons without a placebo arm. Noninferiority depends on the prespecified margin; not proof that doses are identical. Historical regimens are not current dosing guidance.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Zinc research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"zinc","display_name":"Zinc","entity_type_key":"nutrient_element"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The tested lower doses preserved trial-defined efficacy.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[zn-clin-dhingra2020] Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial. (2020). https://pubmed.ncbi.nlm.nih.gov/32966722/ DOI: 10.1056/nejmoa1915905","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"published_estimates","value_text":"10 versus 20 mg: risk difference 1.2 percentage points, upper 98.75% CI 3.3; 5 versus 20 mg: 0.7, upper 2.8. Mean stools 10.7, 10.9, 10.8 (20,10,5 mg); reported differences 0.3 (upper 1.0) and 0.1 (upper 0.8). Indexed published version used; source-version differences retained in paper notes.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Acute diarrheal illness and vomiting","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"f89c7960-23c2-5416-8862-67a4a0729eed","evidence_kind":"source_excerpt","locator":"Lines 1512-1526","start_line":1512,"end_line":1526,"excerpt":"### zn-clin-diarrhea-dose-efficacy\nDiarrhea beyond five days occurred in 6.5%, 7.7% and 7.2% of the 20, 10 and 5 mg groups. The lower doses met the four-percentage-point noninferiority margin; stool counts also met the two-stool margin.\nCondition category: normal\nnutrient_topic: Zinc research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The tested lower doses preserved trial-defined efficacy.\norganism: Homo sapiens\ntissue_or_cell_type: Acute diarrheal illness and vomiting\nexperimental_model: Double-blind randomized multicenter noninferiority trial in 4500 children aged 6–59 months in India and Tanzania\nlimitations: Active-dose comparisons without a placebo arm. Noninferiority depends on the prespecified margin; not proof that doses are identical. Historical regimens are not current dosing guidance.\nexposure: 5, 10 or 20 mg zinc/day using zinc sulfate for 14 days.\ncross_nutrient: Total loose or watery stools after enrollment (co_primary_endpoint)\nevidence_location: Indexed primary abstract; accessible manuscript Methods and Results also inspected.\nevidence_span: {\"source_cache\": \"artifacts/zinc-clinical-sources/dhingra2020.abstract.txt\", \"locator\": \"Primary indexed abstract; complete local file\", \"file_sha256\": \"48deafc698125c49384f5678bf65f3af2a4fc3359510f29a9a94a6b4991ee03e\", \"utf8_bytes\": 2238}\npublished_estimates: 10 versus 20 mg: risk difference 1.2 percentage points, upper 98.75% CI 3.3; 5 versus 20 mg: 0.7, upper 2.8. Mean stools 10.7, 10.9, 10.8 (20,10,5 mg); reported differences 0.3 (upper 1.0) and 0.1 (upper 0.8). Indexed published version used; source-version differences retained in paper notes.\n[zn-clin-dhingra2020] Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial. (2020). https://pubmed.ncbi.nlm.nih.gov/32966722/ DOI: 10.1056/nejmoa1915905","model_system":"Double-blind randomized multicenter noninferiority trial in 4500 children aged 6–59 months in India and Tanzania","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [zn-clin-dhingra2020] Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial. (2020). https://pubmed.ncbi.nlm.nih.gov/32966722/ DOI: 10.1056/nejmoa1915905","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"c5ee0fee-ce5c-58de-905a-10fb0ea0723c","stable_key":"import-6d38d43e-01e4-5641-93be-65654271e242","title":"Zinc: transport, enzyme loading, deficiency and nutrient interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text.","file_path":"","sha256":"2e731dd54477ec1254e97df3323e1208d38f1375effed19252e71ab4f600d13a","revision_id":"c72258b9-ac09-5408-9d44-a921ad1f96a3","review_status":"unverified_draft","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}