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

March 28, 2023 updated by: Umeå University
Role of the exposome on allergy, caries, and neurophysiological development in childhood.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Norrbotten County
      • Luleå, Norrbotten County, Sweden, 97180
        • Sunderby Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

650 families (mother/father/child).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Parents not able to speak or write Swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with excema
Time Frame: Outcome at one year
Excema
Outcome at one year
Number of participants with food allergy
Time Frame: Outcome at one year
Food allergy
Outcome at one year
Number of participants with frhino-conjuctivitis
Time Frame: Outcome at one year
Rhino-conjunctivitis
Outcome at one year
Number of participants with asthma
Time Frame: Outcome at one year
Asthma
Outcome at one year
Number of participants with excema
Time Frame: Outcome at four years
Excema
Outcome at four years
Number of participants with food allergy
Time Frame: Outcome at four years
Food allergy
Outcome at four years
Number of participants with rhino-conjunctivitis
Time Frame: Outcome at four years
Rhino-conjuctivitis
Outcome at four years
Number of participants with asthma
Time Frame: Outcome at four years
Asthma
Outcome at four years
Number of participants with excema
Time Frame: Outcome at six years
Excema
Outcome at six years
Number of participants with food allergy
Time Frame: Outcome at six years
Food allergy
Outcome at six years
Number of participants with rhino-conjunctivitis
Time Frame: Outcome at six years
Rhino-conjunctivitis
Outcome at six years
Number of participants with asthma
Time Frame: Outcome at six years
Asthma
Outcome at six years
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.
Outcome at four years
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.
Outcome at four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

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

Investigators

  • Principal Investigator: Anna Sandin, Ass Prof, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2030

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2013-18-31M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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