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Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial
M. Knip, HK. Åkerblom, E. Al Taji, D. Becker, J. Bruining, L. Castano, T. Danne, C. de Beaufort, HM. Dosch, J. Dupre, WD. Fraser, N. Howard, J. Ilonen, D. Konrad, O. Kordonouri, JP. Krischer, ML. Lawson, J. Ludvigsson, L. Madacsy, JL. Mahon, A....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, Research Support, N.I.H., Extramural, práce podpořená grantem
NLK
Open Access Digital Library
od 1998-01-01 do Před 6 měsíci
Medline Complete (EBSCOhost)
od 1998-01-07 do Před 1 měsícem
PubMed
29297078
DOI
10.1001/jama.2017.19826
Knihovny.cz E-zdroje
- MeSH
- diabetes mellitus 1. typu epidemiologie prevence a kontrola MeSH
- dítě MeSH
- dvojitá slepá metoda MeSH
- fyziologie výživy kojenců MeSH
- kaseiny * MeSH
- lidé MeSH
- náhražky mateřského mléka * MeSH
- následné studie MeSH
- novorozenec MeSH
- přežití bez známek nemoci MeSH
- riziko MeSH
- výživová politika MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Research Support, N.I.H., Extramural MeSH
- srovnávací studie MeSH
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 cow's 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. Trial Registration: clinicaltrials.gov Identifier: NCT00179777.
Centre Hospitalier de Luxembourg Luxembourg City Luxembourg
Charles University 3rd Faculty of Medicine Prague Czech Republic
Children's Hospital of Eastern Ontario Ottawa Ontario Canada
Children's Hospital of Westmead Sydney Australia
Cruces University Hospital UPV EHU CIBERDEM CIBERER Barakaldo Spain
Kinder und Jugendkrankenhaus Auf Der Bult Hannover Germany
Linköping University Linköping Sweden
Medical University of Wroclaw Wroclaw Poland
National Institute of Health and Welfare Helsinki Finland
Semmelweis Medical University Budapest Hungary
Sophia Children's Hospital Rotterdam the Netherlands
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders Madrid Spain
St Michelle Hospital Azienda Ospedaliera Brotzu Diabetes Unit Cagliari Italy
Tartu University Tartu Estonia
Université de Sherbrooke Sherbrooke Quebec Canada
University Campus Bio Medico of Rome Rome Italy
University Children's Hospital Zürich Zürich Switzerland
University of Helsinki Helsinki Finland
University of Helsinki Helsinki Finland Helsinki University Hospital Helsinki Finland
University of Manitoba Winnipeg Manitoba Canada
University of Pittsburgh Pittsburgh Pennsylvania
University of South Florida Tampa
University of Toronto Toronto Ontario Canada
University of Turku and Turku University Hospital Turku Finland
University of Washington Seattle
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