Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial.

摘要: Background Adequate knowledge about the safety of consumption small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. Objective We aimed to test hypothesis that SQ-LNS noninferior control with respect child morbidity. Methods Women (n = 1320) ≤20 wk pregnant were assigned iron and folic acid until delivery no supplementation for offspring; or multiple micronutrient 6 mo postpartum SQ-LNSs postpartum, offspring (6 mg Fe/d) from 18 age [the supplement (LNS) group]. assessed noninferiority (margin ≤20%) between any 2 groups during 0-6 age, non-LNS LNS 6-18 caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, "other illnesses." Results During 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was 3.3 episodes, prevalence (percentage 19.3%, 95% CIs rate ratio (IRR) longitudinal (LPRR) ≤1.20. mo, there 240,097 infant-days group 118,698 group. incidences 4.3 4.3, respectively (IRR: 1.0; CI: 1.0, 1.1), prevalences 28.2% 29.3%, (LPRR: 1.1). Noninferiority inconclusive appetite. Conclusions does not increase reported in this population compared other treatments.This trial registered at clinicaltrials.gov as NCT00970866.