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  • Knip, MikaelUniversity of Helsinki, Finland; Helsinki University Hospital, Finland (author)

Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes The TRIGR Randomized Clinical Trial

  • Article/chapterEnglish2018

Publisher, publication year, extent ...

  • AMER MEDICAL ASSOC,2018
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:liu-144246
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-144246URI
  • https://doi.org/10.1001/jama.2017.19826DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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
  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Akerblom, Hans K.University of Helsinki, Finland (author)
  • Al Taji, EvaCharles University of Prague, Czech Republic (author)
  • Becker, DorothyUniversity of Pittsburgh, PA USA (author)
  • Bruining, JanSophia Childrens University Hospital, Netherlands (author)
  • Castano, LuisUniversity of Basque Country, Spain (author)
  • Danne, ThomasKinder-und Jugendkrankenhaus–Auf der Bult, Hannover, Germany (author)
  • de Beaufort, CarineCentre Hospital Luxembourg, Luxembourg (author)
  • Dosch, Hans-MichaelUniversity of Toronto, Canada (author)
  • Dupre, JohnUniversity of Western Ontario, Canada (author)
  • Fraser, William D.University of Sherbrooke, Canada (author)
  • Howard, NevilleChildrens Hospital Westmead, Australia (author)
  • Ilonen, JormaUniversity of Turku, Finland; Turku University Hospital, Finland (author)
  • Konrad, DanielKinder and Jugendkrankenhaus Auf Der Bult, Germany; University of Childrens Hospital Zurich, Switzerland (author)
  • Kordonouri, OlgaKinder and Jugendkrankenhaus Auf Der Bult, Germany (author)
  • Krischer, Jeffrey P.University of S Florida, FL USA (author)
  • Lawson, Margaret L.Childrens Hospital Eastern Ontario, Canada (author)
  • Ludvigsson, Johnny,1943-Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus(Swepub:liu)johlu29 (author)
  • Madacsy, LaszloSemmelweis University, Hungary (author)
  • Mahon, Jeffrey L.University of Western Ontario, Canada (author)
  • Ormisson, AnneTartu University, Estonia (author)
  • Palmer, Jerry P.University of Washington, WA USA (author)
  • Pozzilli, PaoloUniversity of Campus Biomed Rome, Italy (author)
  • Savilahti, ErkkiUniversity of Helsinki, Finland (author)
  • Serrano-Rios, ManuelCIBERDEM, Spain (author)
  • Songini, MarcoSt Michelle Hospital, Italy (author)
  • Taback, ShayneUniversity of Manitoba, Canada (author)
  • Vaarala, OutiUniversity of Helsinki, Finland; AstraZeneca, Sweden (author)
  • White, Neil H.Washington University, MO USA (author)
  • Virtanen, Suvi M.National Institute Health and Welf, Finland (author)
  • Wasikowa, RenataMedical Academic Wroclaw, Poland (author)
  • University of Helsinki, Finland; Helsinki University Hospital, FinlandUniversity of Helsinki, Finland (creator_code:org_t)

Related titles

  • In:Journal of the American Medical Association (JAMA): AMER MEDICAL ASSOC319:1, s. 38-480098-74841538-3598

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