Trial reportActa paediatrica (Oslo, Norway : 1992)2011
Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes.
Trial report in Acta paediatrica (Oslo, Norway : 1992), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Infant formulas containing hydrolysed protein for prevention of allergic disease.The Cochrane database of systematic reviews · 2018Pooled it
- WITHDRAWN: Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy.The Cochrane database of systematic reviews · 2017Pooled it
- Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy.The Cochrane database of systematic reviews · 2017Pooled it
- Dietary compliance in a randomized double-blind infant feeding trial during infancy aiming at prevention of type 1 diabetes.Food science & nutrition · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
aimThe 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.
methodsThe 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.
resultsA 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.
conclusionThis 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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