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Hydrolyzed infant f...
Hydrolyzed infant formula and early β-cell autoimmunity : a randomized clinical trial.
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- Knip, Mikael (author)
- University of Helsinki, Helsinki, Finland
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- Åkerblom, Hans K (author)
- University of Helsinki, Helsinki, Finland
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- Becker, Dorothy (author)
- University of Pittsburgh, Pittsburgh, Pennsylvania, USA
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- Dosch, Hans-Michael (author)
- University of Toronto, Toronto, Ontario, Canada
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- Dupre, John (author)
- University of Western Ontario, London, Canada
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- Fraser, William (author)
- University of Montréal, Montréal, Québec, Canada
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- Howard, Neville (author)
- Children’s Hospital of Westmead, Sydney, Australia
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- Ilonen, Jorma (author)
- University of Turku, Turku, Finland
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- Krischer, Jeffrey P (author)
- University of South Florida, Tampa, USA
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- Kordonouri, Olga (author)
- Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany
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- Lawson, Margaret L (author)
- Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
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- Palmer, Jerry P (author)
- University of Washington, Seattle, USA
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- Savilahti, Erkki (author)
- University of Helsinki, Helsinki, Finland
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- Vaarala, Outi (author)
- National Institute for Health and Welfare, Helsinki, Finland
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- Virtanen, Suvi M (author)
- National Institute for Health and Welfare, Helsinki, Finland
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(creator_code:org_t)
- American Medical Association (AMA), 2014
- 2014
- English.
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In: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 311:22, s. 2279-2287
- Related links:
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https://jamanetwork....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- IMPORTANCE: The disease process leading to clinical type 1 diabetes often starts during the first years of life. Early exposure to complex dietary proteins may increase the risk of β-cell autoimmunity in children at genetic risk for type 1 diabetes. Extensively hydrolyzed formulas do not contain intact proteins.OBJECTIVE: To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children.DESIGN, SETTING, AND PARTICIPANTS: A double-blind randomized clinical trial of 2159 infants with HLA-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; 1078 were randomized to be weaned to the extensively hydrolyzed casein formula and 1081 were randomized to be weaned to a conventional cows' milk-based formula. The participants were observed to April 16, 2013.INTERVENTIONS: The participants received either a casein hydrolysate or a conventional cows' milk formula supplemented with 20% of the casein hydrolysate.MAIN OUTCOMES: AND MEASURES: Primary outcome was positivity for at least 2 diabetes-associated autoantibodies out of 4 analyzed. Autoantibodies to insulin, glutamic acid decarboxylase, and the insulinoma-associated-2 (IA-2) molecule were analyzed using radiobinding assays and islet cell antibodies with immunofluorescence during a median observation period of 7.0 years (mean, 6.3 years).RESULTS: The absolute risk of positivity for 2 or more islet autoantibodies was 13.4% among those randomized to the casein hydrolysate formula (n = 139) vs 11.4% among those randomized to the conventional formula (n = 117). The unadjusted hazard ratio for positivity for 2 or more autoantibodies among those randomized to be weaned to the casein hydrolysate was 1.21 (95% CI, 0.94-1.54), compared with those randomized to the conventional formula, while the hazard ratio adjusted for HLA risk, duration of breastfeeding, vitamin D use, study formula duration and consumption, and region was 1.23 (95% CI, 0.96-1.58). There were no clinically significant differences in the rate of reported adverse events between the 2 groups.CONCLUSIONS AND RELEVANCE: Among infants at risk for type 1 diabetes, the use of a hydrolyzed formula, when compared with a conventional formula, did not reduce the incidence of diabetes-associated autoantibodies after 7 years. These findings do not support a benefit from hydrolyzed formula. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00179777.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Medicinsk genetik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Medical Genetics (hsv//eng)
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- ref (subject category)
- art (subject category)
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- By the author/editor
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Knip, Mikael
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Åkerblom, Hans K
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Becker, Dorothy
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Dosch, Hans-Mich ...
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Dupre, John
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Fraser, William
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Howard, Neville
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Ilonen, Jorma
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Krischer, Jeffre ...
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Kordonouri, Olga
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Lawson, Margaret ...
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Palmer, Jerry P
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Savilahti, Erkki
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Vaarala, Outi
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Virtanen, Suvi M
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Medical Genetics
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Journal of the A ...
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Linköping University