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ACTIVE NOT RECRUITING
NCT02449850
NA

Preventing Atopic Dermatitis and ALLergies in Children

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

2701

Start Date

2014-12-14

Completion Date

2044-06

Last Updated

2019-08-29

Healthy Volunteers

Yes

Interventions

OTHER

Food intervention

Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

OTHER

Skin care

Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.

Locations (1)

Oslo University Hospital and University of Oslo

Oslo, Norway