PMID- 32783799 OWN - NLM STAT- MEDLINE DCOM- 20201123 LR - 20220902 IS - 1476-1645 (Electronic) IS - 0002-9637 (Print) IS - 0002-9637 (Linking) VI - 103 IP - 4 DP - 2020 Oct TI - Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial. PG - 1397-1404 LID - 10.4269/ajtmh.19-0918 [doi] AB - Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 x 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z-score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions. FAU - Parpia, Tarina C AU - Parpia TC AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - Elwood, Sarah E AU - Elwood SE AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - Scharf, Rebecca J AU - Scharf RJ AD - 2Department of Pediatrics, University of Virginia, Charlottesville, Virginia. FAU - McDermid, Joann M AU - McDermid JM AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - Wanjuhi, Anne W AU - Wanjuhi AW AD - 2Department of Pediatrics, University of Virginia, Charlottesville, Virginia. FAU - Rogawski McQuade, Elizabeth T AU - Rogawski McQuade ET AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - Gratz, Jean AU - Gratz J AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - Svensen, Erling AU - Svensen E AD - 3Haukeland University Hospital, Bergen, Norway. FAU - Swann, Jonathan R AU - Swann JR AD - 4School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom. FAU - Donowitz, Jeffrey R AU - Donowitz JR AD - 5Division of Infectious Disease, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia. FAU - Jatosh, Samwel AU - Jatosh S AD - 6Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania. FAU - Katengu, Siphael AU - Katengu S AD - 6Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania. FAU - Mdoe, Paschal AU - Mdoe P AD - 6Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania. FAU - Kivuyo, Sokoine AU - Kivuyo S AD - 7National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania. FAU - Houpt, Eric R AU - Houpt ER AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. FAU - DeBoer, Mark D AU - DeBoer MD AD - 2Department of Pediatrics, University of Virginia, Charlottesville, Virginia. FAU - Mduma, Estomih AU - Mduma E AD - 6Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania. FAU - Platts-Mills, James A AU - Platts-Mills JA AD - 1Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia. LA - eng GR - T32 AI007046/AI/NIAID NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - Am J Trop Med Hyg JT - The American journal of tropical medicine and hygiene JID - 0370507 RN - 0 (Nitro Compounds) RN - 0 (Thiazoles) RN - 25X51I8RD4 (Niacinamide) RN - 83905-01-5 (Azithromycin) RN - SOA12P041N (nitazoxanide) SB - IM MH - Adult MH - Azithromycin/therapeutic use MH - Body Weight MH - Child Health/*statistics & numerical data MH - Child Nutrition Disorders MH - Child, Preschool MH - Cohort Studies MH - Early Medical Intervention MH - Female MH - Humans MH - Infant MH - Infant, Newborn MH - Male MH - Mothers MH - Neonatal Sepsis/drug therapy/epidemiology MH - Niacinamide/therapeutic use MH - Nitro Compounds MH - Poverty MH - Respiratory Tract Infections/drug therapy/epidemiology MH - Rural Population MH - Seasons MH - Surveys and Questionnaires/*statistics & numerical data MH - Tanzania/epidemiology MH - Thiazoles/therapeutic use MH - Young Adult PMC - PMC7543831 COIS- Financial support: This work is supported by the Bill & Melinda Gates Foundation, OPP1141342 to E. M.; NIH 5T32AI007046-43 to T. C. P.; DDCF CSDA 2014113 to R. J. S. EDAT- 2020/08/14 06:00 MHDA- 2020/11/24 06:00 PMCR- 2020/08/10 CRDT- 2020/08/14 06:00 PHST- 2020/08/14 06:00 [pubmed] PHST- 2020/11/24 06:00 [medline] PHST- 2020/08/14 06:00 [entrez] PHST- 2020/08/10 00:00 [pmc-release] AID - tpmd190918 [pii] AID - 10.4269/ajtmh.19-0918 [doi] PST - ppublish SO - Am J Trop Med Hyg. 2020 Oct;103(4):1397-1404. doi: 10.4269/ajtmh.19-0918.