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Active, not recruitingNCT05809479NICEUpdated Apr 12, 2023

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

An observational study in Chronic Diseases in Children, sponsored by Umeå University. Active, not recruiting at 1 site in Sweden. Open to participants aged Up to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Umeå University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,950
Ages
Up to 6 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Chronic Diseases in Children

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03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's enrollment of 1,950 is above the median of 419 across 249 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

650 families (mother/father/child).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents not able to speak or write Swedish
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,950 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Number of participants with excema

    Excema

    Time frame: Outcome at one year

  2. Number of participants with food allergy

    Food allergy

    Time frame: Outcome at one year

  3. Number of participants with frhino-conjuctivitis

    Rhino-conjunctivitis

    Time frame: Outcome at one year

  4. Number of participants with asthma

    Asthma

    Time frame: Outcome at one year

  5. Number of participants with excema

    Excema

    Time frame: Outcome at four years

  6. Number of participants with food allergy

    Food allergy

    Time frame: Outcome at four years

  7. Number of participants with rhino-conjunctivitis

    Rhino-conjuctivitis

    Time frame: Outcome at four years

  8. Number of participants with asthma

    Asthma

    Time frame: Outcome at four years

  9. Number of participants with excema

    Excema

    Time frame: Outcome at six years

  10. Number of participants with food allergy

    Food allergy

    Time frame: Outcome at six years

  11. Number of participants with rhino-conjunctivitis

    Rhino-conjunctivitis

    Time frame: Outcome at six years

  12. Number of participants with asthma

    Asthma

    Time frame: Outcome at six years

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

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

    Time frame: Outcome at four years

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

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

    Time frame: Outcome at four years

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Study locations

1 site
  • Sunderby Hospital
    Luleå, Norrbotten County 97180, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05809479
Lead sponsor
Umeå University
Collaborators
Göteborg University, Chalmers University of Technology, Karolinska Institutet, Region Norrbotten, The Swedish Research Council, Forte, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
Jun 2015
Primary completion
Jun 2024 (estimated)
Completion
Jun 2030 (estimated)
Last update
Apr 12, 2023

Study contacts

Anna Sandin, Ass Prof
principal investigator · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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