{"id":"a2bb0767-a6ab-54f4-8751-355cf20cefa3","stable_key":"aaa7baba-8689-56ab-ba1e-b71542bcb8e9:iod-clin-lactation-hypofunction","predicate":"maternal-route-reduces","statement":"Infant thyroid hypofunction classifications were less frequent with indirect maternal supplementation (P=0.023), although infant TSH and T4 concentrations did not differ significantly between groups over time (P=0.597 and 0.184).","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"negative","is_public":true,"mechanism_event_id":"0c9c4a6a-6204-58b4-8a1d-a922e501b9c1","mechanism_event_label":"A categorical thyroid outcome improved even though average hormone comparisons were not significant.","subject":{"id":"a6c8a491-944e-5f9a-9caf-6e9063b9030f","slug":"iodized-oil","display_name":"Iodized oil preparation","entity_type_key":"chemical_species"},"object":{"id":"da0bb328-c478-50f6-b29b-183bcdebb096","slug":"infant-thyroid-hypofunction","display_name":"Infant thyroid hypofunction classification","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"0c9c4a6a-6204-58b4-8a1d-a922e501b9c1","stable_key":"aaa7baba-8689-56ab-ba1e-b71542bcb8e9:iod-clin-lactation-hypofunction-event","event_type":"observed_intervention","label":"A categorical thyroid outcome improved even though average hormone comparisons were not significant.","description":"Infant thyroid hypofunction classifications were less frequent with indirect maternal supplementation (P=0.023), although infant TSH and T4 concentrations did not differ significantly between groups over time (P=0.597 and 0.184).","status":"provisional","compartment":null,"participants":[{"entity":{"id":"0e0ac6d1-3336-506a-9f69-5838ca1500ed","slug":"iodine","display_name":"Iodine","entity_type_key":"nutrient_element"},"role":"supplemented nutrient","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"b2450167-5a3a-5f1d-8933-8b46c25e9dff","slug":"serum-tsh-concentration","display_name":"Serum TSH concentration","entity_type_key":"cellular_process"},"role":"assayed endpoint","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"90c33fc7-1fee-5949-a863-a7848a22123f","slug":"serum-total-t4-concentration","display_name":"Serum total thyroxine concentration","entity_type_key":"cellular_process"},"role":"assayed endpoint","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""},{"entity":{"id":"a6c8a491-944e-5f9a-9caf-6e9063b9030f","slug":"iodized-oil","display_name":"Iodized oil preparation","entity_type_key":"chemical_species"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":3,"notes":""},{"entity":{"id":"da0bb328-c478-50f6-b29b-183bcdebb096","slug":"infant-thyroid-hypofunction","display_name":"Infant thyroid hypofunction classification","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":4,"notes":""}]},"contexts":[{"dimension":"availability_state","value_text":"nutrient_deficiency","comparator":null,"unit":null,"notes":"Imported condition classification; unverified.","entity":null},{"dimension":"cross_nutrient","value_text":"false","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_location","value_text":"Primary PDF Methods, trial profile, Results and Table2, pp.197–209.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Double-blind randomized trial in Morocco;241 mother–infant pairs enrolled, 239 randomized after two age exclusions","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Term infants ≤ 8 weeks; indirect arm 121 pairs: mother 400 mg iodine as oral iodized poppyseed oil, infant placebo; direct arm 118 pairs: infant about 100 mg iodine from half a 200 mg oil capsule, mother placebo; follow-up 3, 6, 9 months.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Both arms received active iodine somewhere in the pair; there was no wholly untreated arm. Breastfeeding and baseline deficiency contextualize the result; measured iodine status is not a child cognitive outcome. Actual infant study dose was about 100 mg, not the 200 mg guideline discussed elsewhere in the paper. No serious adverse events were reported; this does not establish safety for other infant doses, preparations or settings.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Iodine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"iodine","display_name":"Iodine","entity_type_key":"nutrient_element"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"A categorical thyroid outcome improved even though average hormone comparisons were not significant.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[iod-clin-bouhouch2014] Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. (2014). https://pubmed.ncbi.nlm.nih.gov/24622750/ DOI: 10.1016/s2213-8587(13)70155-4","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Breast milk, infant urine and thyroid function","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"trigger_kind","value_text":"nutrient_deficiency","comparator":null,"unit":null,"notes":"Imported condition classification; unverified.","entity":null}],"evidence":[{"id":"d646ab8f-5851-534a-a308-4084e74e3a43","evidence_kind":"source_excerpt","locator":"Lines 1566-1578","start_line":1566,"end_line":1578,"excerpt":"### iod-clin-lactation-hypofunction\nInfant thyroid hypofunction classifications were less frequent with indirect maternal supplementation (P=0.023), although infant TSH and T4 concentrations did not differ significantly between groups over time (P=0.597 and 0.184).\nCondition category: nutrient_deficiency\nnutrient_topic: Iodine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: A categorical thyroid outcome improved even though average hormone comparisons were not significant.\norganism: Homo sapiens\ntissue_or_cell_type: Breast milk, infant urine and thyroid function\nexperimental_model: Double-blind randomized trial in Morocco;241 mother–infant pairs enrolled, 239 randomized after two age exclusions\nlimitations: Both arms received active iodine somewhere in the pair; there was no wholly untreated arm. Breastfeeding and baseline deficiency contextualize the result; measured iodine status is not a child cognitive outcome. Actual infant study dose was about 100 mg, not the 200 mg guideline discussed elsewhere in the paper. No serious adverse events were reported; this does not establish safety for other infant doses, preparations or settings.\nexposure: Term infants ≤ 8 weeks; indirect arm 121 pairs: mother 400 mg iodine as oral iodized poppyseed oil, infant placebo; direct arm 118 pairs: infant about 100 mg iodine from half a 200 mg oil capsule, mother placebo; follow-up 3, 6, 9 months.\ncross_nutrient: false\nevidence_location: Primary PDF Methods, trial profile, Results and Table2, pp.197–209.\n[iod-clin-bouhouch2014] Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. (2014). https://pubmed.ncbi.nlm.nih.gov/24622750/ DOI: 10.1016/s2213-8587(13)70155-4","model_system":"Double-blind randomized trial in Morocco;241 mother–infant pairs enrolled, 239 randomized after two age exclusions","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [iod-clin-bouhouch2014] Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. 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