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Randomized Controlled Trial
. 2011 Apr;100(4):557-64.
doi: 10.1111/j.1651-2227.2010.02107.x. Epub 2011 Jan 10.

Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes

S M Virtanen  1 , S Bärlund, M Salonen, E Savilahti, A Reunanen, J Paronen, A-M Hämäläinen, J Ilonen, K Teramo, M Erkkola, A Ormisson, Ü Einberg, M-A Riikjärv, J G Ludvigsson, M Knip, H K Åkerblom; Finnish TRIGR Study Group
Affiliations
Randomized Controlled Trial

Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes

S M Virtanen et al. Acta Paediatr. 2011 Apr.

Abstract

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 cow's milk and casein were higher in the cow's milk-based formula group than in the hydrolysed formula group during the intervention period (p<0.05), reflecting the difference in the intake of cow's 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.

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Conflict of interest statement

CONFLICT OF INTEREST

None of the authors had a personal or financial conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the Finnish study population.
Figure 2
Figure 2
(A–D) Median levels of (A) cow’s milk–based formula IgG antibodies, (B) cow’s milk–based formula IgA antibodies, (C) casein IgG antibodies and (D) casein IgA antibodies in the Finnish children in the hydrolysed and cow’s milk–based formula groups. Up to the ages of 6 and 9 months, the area under the curve (AUC) was smaller in the hydrolysed than in the cow’s milk–based formula group for all four antibodies (p < 0.05). Up to the age of 12 months, the AUC was smaller for cow’s milk–based formula IgG, casein IgG and casein IgA, and up to the age of 18 months, the AUC was smaller for cow’s milk–based formula IgG in the hydrolysed than in the cow’s milk-based formula group (p < 0.05).
Figure 3
Figure 3
Body mass index [weight (kg) / height (m)2] up to the age of 2 years in the Finnish children in the hydrolysed and cow’s milk–based formula groups.
See this image and copyright information in PMC

References

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