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.
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.
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DOI：
10.1093/jn/nxz243
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发表时间：
2020-02-01
期刊：
影响因子：
--
通讯作者：
Dewey KG
中科院分区：
文献类型：
--
作者：
Adu-Afarwuah S;Young RR;Lartey A;Okronipa H;Ashorn P;Ashorn U;Oaks BM;Dewey KG
需要充分了解食用少量脂质营养补充剂（SQ-LNS）的安全性。我们的目的是检验这一假设，即SQ-LNS消费是不劣于控制方面的儿童发病率妇女（n = 1320）妊娠≤20周的孕妇被分配到铁和叶酸直到分娩，后代不补充;或多种微量营养素补充直到产后6个月，后代不补充;或SQ-LNS直至产后6个月，以及SQ-LNS用于6至18个月龄的后代（6 mg Fe/d）[脂质基营养补充剂（LNS组）]。我们评估了0-6月龄期间任何2组之间以及6-18月龄期间非LNS和LNS组之间在无病例报告的急性呼吸道感染、腹泻、胃肠炎、发热/疑似疟疾、食欲不振和“其他疾病”方面的非劣效性（界值≤20%）。在0-6月龄期间，1197名婴儿贡献了190，503个婴儿日。对于合并的所有发病率，总体平均发病率（每100个婴儿日）为3.3次发作，总体平均患病率（婴儿日百分比）为19.3%，任何2组之间的发病率比（IRR）和纵向患病率比（LPRR）的95% CI ≤1.20。在6-18个月期间，非LNS组有240,097个婴儿日，LNS组有118,698个婴儿日。对于合并的所有发病率，组平均发生率分别为4.3和4.3（IRR：1.0; 95% CI：1.0，1.1），平均患病率分别为28.2%和29.3%（LPRR：1.0; 95% CI：1.0，1.1）。腹泻、发热/疑似疟疾和食欲不振的非劣效性不确定。与其他2种治疗相比，SQ-LNS消耗量未增加该人群中报告的总体儿童发病率。本试验在clinicaltrials.gov上注册为NCT 00970866。2019;00：1-12.
Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity Women (n = 1320) ≤20 wk pregnant were assigned to iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6 mo postpartum with no supplementation for offspring; or SQ-LNSs until 6 mo postpartum, and SQ-LNSs for offspring (6 mg Fe/d) from 6 to 18 mo of age [the lipid-based nutrient supplement (LNS) group]. We assessed noninferiority (margin ≤20%) between any 2 groups during 0-6 mo of age, and between the non-LNS and LNS groups during 6-18 mo of age for caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and “other illnesses.” During 0-6 mo of age, 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was3.3 episodes, overall mean prevalence (percentage of infant-days) was 19.3%, and the 95% CIs of the incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR) between any 2 groups were ≤1.20. During 6-18 mo, there were 240,097 infant-days for the non-LNS group and 118,698 for the LNS group. For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively (IRR: 1.0; 95% CI: 1.0, 1.1), and mean prevalences were 28.2% and 29.3%, respectively (LPRR: 1.0; 95% CI: 1.0,1.1). Noninferiority was inconclusive for diarrhea, fever/suspected malaria, and poor appetite. SQ-LNS consumption does not increase reported overall child morbidity in this population compared with the 2 other treatments. This trial was registered at clinicaltrials.gov as NCT00970866. J Nutr 2019;00:1-12.
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影响因子：
11.4
作者：
Baker KK;Senesac R;Sewell D;Sen Gupta A;Cumming O;Mumma J
通讯作者：
Mumma J
影响因子：
7.1
作者：
Adu-Afarwuah, Seth;Lartey, Anna;Dewey, Kathryn G.
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Dewey, Kathryn G.
影响因子：
3.4
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Dewey, Kathryn G.
影响因子：
7.7
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通讯作者：
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影响因子：
4.2
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通讯作者：
Dewey, Kathryn G.