Preventing Atopic Dermatitis and ALLergies in Children

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.

Conditions

• Atopic Dermatitis
• Food Allergy in Children
• Asthma
• Rhinitis, Allergic
• Non-communicable Diseases
• Obesity
• Cardiovascular Disease

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.

Sponsors & Collaborators

• University of Oslo

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• University Hospital, Akershus

  collaborator OTHER

• Ostfold Hospital Trust

  collaborator OTHER

• ThermoFisher Scientific Brahms Biomarkers France

  collaborator INDUSTRY

• University of Southampton

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Norwegian University of Life Sciences

  collaborator OTHER

• Diakonova University College

  collaborator OTHER

• Norwegian Department of Health and Social Affairs

  collaborator OTHER_GOV

• University Medical Center Groningen

  collaborator OTHER

• Furst Medical Laboratory

  collaborator UNKNOWN

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Karin C. Lødrup Carlsen, MD PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-12-14

Primary Completion

2020-07-31

Completion

2044-06-30

Countries

• Norway

Study Locations