Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes.
Acta Paediatr
; 100(4): 557-64, 2011 Apr.
Article
em En
| MEDLINE
| ID: mdl-21114527
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Prevenção Primária
/
Cooperação do Paciente
/
Fórmulas Infantis
/
Diabetes Mellitus Tipo 1
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Qualitative_research
/
Risk_factors_studies
Limite:
Animals
/
Humans
/
Infant
Idioma:
En
Revista:
Acta Paediatr
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Finlândia