TY  - JOUR
T1  - REmoval of bovine insulin from cow's milk formula and early initiation of beta-cell autoimmunity in the findia pilot study
AU  - Vaarala O, Ilonen J, Ruohtula T, et al
Y1  - 2012/07/01
N1  - 10.1001/archpediatrics.2011.1559
JO  - Archives of Pediatrics & Adolescent Medicine
SP  - 608
EP  - 614
VL  - 166
IS  - 7
N2  - Objective 
                  To test whether weaning to a bovine insulin–free cow's milk formula (CMF) reduces type 1 diabetes mellitus–associated autoantibodies in children at genetic risk.Design 
                  Randomized, double-blind pilot trial (Finnish Dietary Intervention Trial for the Prevention of Type 1 Diabetes [FINDIA]).Setting 
                  Three pediatric hospitals in Finland from May 15, 2002, to November 22, 2005.Participants 
                  A total of 1113 infants with HLA-conferred susceptibility to type 1 diabetes were randomly assigned to receive study infant formulas; 908 children provided at least 1 follow-up blood sample (last follow-up, June 2009).Intervention 
                  The CMF (n = 389), whey-based hydrolyzed formula (WHF) (n = 350), or whey-based FINDIA formula essentially free of bovine insulin (n = 365) during the first 6 months of life whenever breast milk was not available.Main Outcome Measures 
                  Primary outcome was beta-cell autoimmunity monitored at ages 3, 6, and 12 months and then annually until age 3 years. Autoantibodies to insulin, the 65-kDa isoform of glutamic acid decarboxylase, and the tyrosine phosphatase–related IA-2 molecule were screened, and islet cell autoantibodies and autoantibodies to zinc transporter 8 were analyzed in infants whose primary screening test results were positive.Results 
                  In the intention-to-treat analysis, 6.3% of children in the CMF group, 4.9% of those in the WHF group, and 2.6% of children in the FINDIA group were positive for at least 1 autoantibody by age 3 years. The odds ratios were 0.75 (95% CI, 0.37-1.54) in the WHF group and 0.39 (0.17-0.91) in the FINDIA group when compared with the CMF group. In the treatment-received analysis, the corresponding odds ratios were 0.81 (95% CI, 0.37-1.76) and 0.23 (0.08-0.69).Conclusion 
                  In comparison with ordinary CMF, weaning to an insulin-free CMF reduced the cumulative incidence of autoantibodies by age 3 years in children at genetic risk of type 1 diabetes mellitus.Trial Registration 
                  clinicaltrials.gov Identifier: NCT01055080
SN  - 1072-4710
M3  - doi: 10.1001/archpediatrics.2011.1559
UR  - http://dx.doi.org/10.1001/archpediatrics.2011.1559
ER  -