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


CONCLUSIONS
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.
Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.
S M
SM
Virtanen
S
S
Bärlund
M
M
Salonen
E
E
Savilahti
A
A
Reunanen
J
J
Paronen
A-M
AM
Hämäläinen
J
J
Ilonen
K
K
Teramo
M
M
Erkkola
A
A
Ormisson
Ü
Ü
Einberg
M-A
MA
Riikjärv
J G
JG
Ludvigsson
M
M
Knip
H K
HK
Åkerblom
D000818:Animals; D002364:Caseins / Q000032:analysis; D003922:Diabetes Mellitus, Type 1 / Q000235:genetics / Q000517:prevention & control*; D005240:Feasibility Studies; D020022:Genetic Predisposition to Disease; D006801:Humans; D007070:Immunoglobulin A / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage* / Q000737:chemistry; D007227:Infant Nutritional Physiological Phenomena; D008892:Milk / Q000737:chemistry; D010349:Patient Compliance / Q000706:statistics & numerical data*; D010865:Pilot Projects; D011322:Primary Prevention / Q000379:methods*
D002364:Caseins; D007070:Immunoglobulin A; D007074:Immunoglobulin G