title: Study protocol to investigate the environmental and genetic aetiology of atopic dermatitis: the Indonesian Prospective Study of Atopic Dermatitis in Infants (ISADI).
abstract: Atopic dermatitis (AD) is the most common skin disorder in young children worldwide, with a high impact on morbidity and quality of life. To date, no prospective study has been published on the incidence and potential predictors of AD in South East Asian populations. The Indonesian Prospective Study of Atopic Dermatitis in Infants (ISADI) will address the genetic, metabolic and dietary characteristics of mothers and their offspring, as well as potential determinants of AD within the first year of infant life.
  
  
  
  This prospective study will be undertaken in about 400 infants to investigate the direct and indirect effects of filaggrin (FLG) gene mutations, the genetic variants ofFADS1,FADS2andFADS3and the role of long-chain polyunsaturated fatty acids (LCPUFA) on the development of AD. We will use standardised protocols for subject recruitment, umbilical artery plasma analysis, buccal cell sampling for genotyping, fatty acid analysis, physical exams, 3-day food-intake recall of mothers and children, as well as comprehensive questionnaires on environmental, socioeconomic and AD-related factors, including family history. Monthly monitoring by telephone and physical exams every 3 months will be carried out to assess participants' anthropometry, medical history and incidence of AD diagnosis during the first year of life. Hypotheses-driven analyses of quality-controlled dietary, genetic and metabolic data will be performed with state-of-the-art statistical methods (eg, AD-event history, haplotype, dietary or metabolic factor analysis). Direct and indirect effects of genetics and LCPUFA in buccal cell and cord plasma glycerophospholipids as potential mediators of inflammation on AD development will be evaluated by path analysis.
  
  
  
  The Permanent Medical Research Ethics Committee in Medicine and Health/Faculty of Medicine Universitas Indonesia/Dr Cipto Mangunkusumo Hospital (No. 47/H2.F1/ETIK/2014) approved the study protocol (extended by the letter no. 148/UN2.F1/ETIK/2015). We aim to disseminate our findings via publication in an international journal with high impact factor.
authors.affiliation: Postgraduate Program, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.|Pantai Indah Kapuk Hospital, Jakarta, Indonesia.
authors.forename: Conny
authors.initials: C
authors.lastname: Tanjung
authors.affiliation: Division of Metabolic and Nutritional Medicine, Ludwig-Maximilians-Universität München, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Rzehak
authors.affiliation: Faculty of Community Medicine, Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Muchtaruddin
authors.initials: M
authors.lastname: Mansyur
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia.
authors.forename: Zakiudin
authors.initials: Z
authors.lastname: Munasir
authors.affiliation: Faculty of Medicine, Sydney University, Sydney, Australia.|Department of Medical Biology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Herawati
authors.initials: H
authors.lastname: Sudoyo
authors.affiliation: Department of Clinical Pathology, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia.
authors.forename: Suzanna
authors.initials: S
authors.lastname: Immanuel
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Universitas Airlangga, Dr Sutomo General Hospital, Surabaya, Indonesia.
authors.forename: Roedi
authors.initials: R
authors.lastname: Irawan
authors.affiliation: Research Unit of Molecular Epidemiology, Institute of Epidemiology II, Helmholtz Zentrum Muenchen, Munich, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Reischl
authors.affiliation: Division of Metabolic and Nutritional Medicine, Ludwig-Maximilians-Universität München, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.
authors.forename: Hans
authors.initials: H
authors.lastname: Demmelmair
authors.affiliation: Division of Metabolic and Nutritional Medicine, Ludwig-Maximilians-Universität München, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Koletzko
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia.
authors.forename: Sri Rezeki
authors.initials: SR
authors.lastname: Hadinegoro
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Universitas Indonesia, Dr Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia.
authors.forename: Damayanti Rusli
authors.initials: DR
authors.lastname: Sjarif
mesh_terms: D015331:Cohort Studies; D003430:Cross-Sectional Studies; D000090943:Delta-5 Fatty Acid Desaturase; D003876:Dermatitis, Atopic / Q000453:epidemiology*; D004781:Environmental Exposure / Q000009:adverse effects* / Q000706:statistics & numerical data*; D005260:Female; D000091344:Filaggrin Proteins; D020022:Genetic Predisposition to Disease / Q000453:epidemiology*; D006801:Humans; D007214:Indonesia; D007223:Infant; D008137:Longitudinal Studies; D008297:Male; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors
keywords: Atopic dermatitis; FADS gene polymorphism; Filaggrin gene mutation; Long chain poly unsaturated fatty acid composition