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Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes
National Institute of Health and Welfare, Helsinki.
National Institute of Health and Welfare, Helsinki.
University of Helsinki.
University of Helsinki.
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2011 (English)In: ACTA PAEDIATRICA, ISSN 0803-5253, Vol. 100, no 4, 557-564 p.Article in journal (Refereed) Published
Abstract [en]

Aim: The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) was launched to determine whether weaning to a highly hydrolysed formula in infancy reduces the incidence of type 1 diabetes in children at increased genetic disease susceptibility. We describe here the findings on feasibility and compliance from the pilot study. Methods: The protocol was tested in 240 children. The diet of the participating children was assessed by self-administered dietary forms, a structured questionnaire and a food record. Blood samples were taken and weight and height measured at birth and at 3, 6, 9, 12, 18 and 24 months. Results: A majority of the subjects (84%) were exposed to the study formula at least for 2 months. Linear growth or weight gain over the first 2 years of life was similar in the two study groups. The levels of IgA and IgG antibodies to cows milk and casein were higher in the cows milk-based formula group than in the hydrolysed formula group during the intervention period (p andlt; 0.05), reflecting the difference in the intake of cows milk protein. Conclusion: This randomized trial on infant feeding turned out to be feasible, and dietary compliance was acceptable. Valuable experience was gained for the planning and sample size estimation of the study proper.

Place, publisher, year, edition, pages
Blackwell Publishing Ltd , 2011. Vol. 100, no 4, 557-564 p.
Keyword [en]
Compliance, Feasibility, Hydrolysed infant formula, Infants, Primary prevention
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-67325DOI: 10.1111/j.1651-2227.2010.02107.xISI: 000288451800020OAI: diva2:409370
Available from: 2011-04-08 Created: 2011-04-08 Last updated: 2011-04-08

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Ludvigsson, Johnny
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PediatricsFaculty of Health SciencesDepartment of Paediatrics in Linköping
Medical and Health Sciences

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