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NCT Number: NCT05809479

NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment

Role of the exposome on allergy, caries, and neurophysiological development in childhood.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Diseases in Children

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunderby Hospital

Luleå, Norrbotten County, 97180, Sweden

About this study

Role of the exposome and epigenetics on allergy, caries, and neurophysiological development in childhood as studied in a birth cohort of 650 trioses. The exposome includes repeated measures of nutrition, micronutritients, microbiota, toxic agents and the clinical outcomes, diagnoses of allergy, caries and neurophysiological functions/dysfunctions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018

Exclusion criteria

  • Parents not able to speak or write Swedish

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Number of participants with excema

    Time frame: Outcome at one year

    Excema

  2. Number of participants with food allergy

    Time frame: Outcome at one year

    Food allergy

  3. Number of participants with frhino-conjuctivitis

    Time frame: Outcome at one year

    Rhino-conjunctivitis

  4. Number of participants with asthma

    Time frame: Outcome at one year

    Asthma

  5. Number of participants with excema

    Time frame: Outcome at four years

    Excema

  6. Number of participants with food allergy

    Time frame: Outcome at four years

    Food allergy

  7. Number of participants with rhino-conjunctivitis

    Time frame: Outcome at four years

    Rhino-conjuctivitis

  8. Number of participants with asthma

    Time frame: Outcome at four years

    Asthma

  9. Number of participants with excema

    Time frame: Outcome at six years

    Excema

  10. Number of participants with food allergy

    Time frame: Outcome at six years

    Food allergy

  11. Number of participants with rhino-conjunctivitis

    Time frame: Outcome at six years

    Rhino-conjunctivitis

  12. Number of participants with asthma

    Time frame: Outcome at six years

    Asthma

  13. Numbers of caries lesions (DeMFS = decayed, enamel included, missed, filled, tooth surfaces, in each child

    Time frame: Outcome at four years

    Cariesfree individuals have a DeMFS = 0 and increasing scores means increasing degree of caries. Maximum DeMFS = 148, minumum DeMFS = 0.

  14. Child cognition as measured by Wechsler Preschool and Primary Scale of Intelligence

    Time frame: Outcome at four years

    Cognitive development will be tested face-to-face with Wechsler Preschool and Primary Scale of Intelligence. Increasing scores means increasing intelligence.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Chalmers University of Technology
  • Forte
  • Göteborg University
  • Karolinska Institutet
  • Region Norrbotten
  • The Swedish Research Council
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Registry information

Acronym: NICE

Important dates

Study start
2015
Primary completion
2024
Study completion
2030
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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