Sökning: WFRF:(Pozzilli Paolo) > Effect of Hydrolyze...
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000 | 07400naa a2200673 4500 | |
001 | oai:DiVA.org:liu-144246 | |
003 | SwePub | |
008 | 180122s2018 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-1442462 URI |
024 | 7 | a https://doi.org/10.1001/jama.2017.198262 DOI |
040 | a (SwePub)liu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Knip, Mikaelu University of Helsinki, Finland; Helsinki University Hospital, Finland4 aut |
245 | 1 0 | a Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes The TRIGR Randomized Clinical Trial |
264 | 1 | b AMER MEDICAL ASSOC,c 2018 |
338 | a electronic2 rdacarrier | |
500 | a Funding Agencies|Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD); National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health [HD040364, HD042444, HD051997]; Canadian Institutes of Health Research; Commission of the European Communities [QLK1-2002-00372]; European Foundation for the Study of Diabates/JDRF/Novo Nordisk; Academy of Finland (Centre of Excellence in Molecular Systems Immunology and Physiology Research) [250114]; Dutch Diabetes Research Foundation; Finnish Diabetes Research Foundation; JDRF | |
520 | a IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. INTERVENTIONS The participants received either a casein hydrolysate or a conventional adapted cows milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. MAIN OUTCOMES AND MEASURES Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). RESULTS Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8%[95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng |
700 | 1 | a Akerblom, Hans K.u University of Helsinki, Finland4 aut |
700 | 1 | a Al Taji, Evau Charles University of Prague, Czech Republic4 aut |
700 | 1 | a Becker, Dorothyu University of Pittsburgh, PA USA4 aut |
700 | 1 | a Bruining, Janu Sophia Childrens University Hospital, Netherlands4 aut |
700 | 1 | a Castano, Luisu University of Basque Country, Spain4 aut |
700 | 1 | a Danne, Thomasu Kinder-und Jugendkrankenhaus–Auf der Bult, Hannover, Germany4 aut |
700 | 1 | a de Beaufort, Carineu Centre Hospital Luxembourg, Luxembourg4 aut |
700 | 1 | a Dosch, Hans-Michaelu University of Toronto, Canada4 aut |
700 | 1 | a Dupre, Johnu University of Western Ontario, Canada4 aut |
700 | 1 | a Fraser, William D.u University of Sherbrooke, Canada4 aut |
700 | 1 | a Howard, Nevilleu Childrens Hospital Westmead, Australia4 aut |
700 | 1 | a Ilonen, Jormau University of Turku, Finland; Turku University Hospital, Finland4 aut |
700 | 1 | a Konrad, Danielu Kinder and Jugendkrankenhaus Auf Der Bult, Germany; University of Childrens Hospital Zurich, Switzerland4 aut |
700 | 1 | a Kordonouri, Olgau Kinder and Jugendkrankenhaus Auf Der Bult, Germany4 aut |
700 | 1 | a Krischer, Jeffrey P.u University of S Florida, FL USA4 aut |
700 | 1 | a Lawson, Margaret L.u Childrens Hospital Eastern Ontario, Canada4 aut |
700 | 1 | a Ludvigsson, Johnny,d 1943-u Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus4 aut0 (Swepub:liu)johlu29 |
700 | 1 | a Madacsy, Laszlou Semmelweis University, Hungary4 aut |
700 | 1 | a Mahon, Jeffrey L.u University of Western Ontario, Canada4 aut |
700 | 1 | a Ormisson, Anneu Tartu University, Estonia4 aut |
700 | 1 | a Palmer, Jerry P.u University of Washington, WA USA4 aut |
700 | 1 | a Pozzilli, Paolou University of Campus Biomed Rome, Italy4 aut |
700 | 1 | a Savilahti, Erkkiu University of Helsinki, Finland4 aut |
700 | 1 | a Serrano-Rios, Manuelu CIBERDEM, Spain4 aut |
700 | 1 | a Songini, Marcou St Michelle Hospital, Italy4 aut |
700 | 1 | a Taback, Shayneu University of Manitoba, Canada4 aut |
700 | 1 | a Vaarala, Outiu University of Helsinki, Finland; AstraZeneca, Sweden4 aut |
700 | 1 | a White, Neil H.u Washington University, MO USA4 aut |
700 | 1 | a Virtanen, Suvi M.u National Institute Health and Welf, Finland4 aut |
700 | 1 | a Wasikowa, Renatau Medical Academic Wroclaw, Poland4 aut |
710 | 2 | a University of Helsinki, Finland; Helsinki University Hospital, Finlandb University of Helsinki, Finland4 org |
773 | 0 | t Journal of the American Medical Association (JAMA)d : AMER MEDICAL ASSOCg 319:1, s. 38-48q 319:1<38-48x 0098-7484x 1538-3598 |
856 | 4 | u https://liu.diva-portal.org/smash/get/diva2:1176314/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print |
856 | 4 | u https://jamanetwork.com/journals/jama/articlepdf/2667723/jama_knip_2018_oi_170152.pdf |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-144246 |
856 | 4 8 | u https://doi.org/10.1001/jama.2017.19826 |
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