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

Active, not recruiting

• Conditions: Chronic Diseases in Children

• Registration Number: NCT05809479
• Lead Sponsor: Umeå University

Brief Summary

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

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 Timeline

• Study Start: 2015-06
• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1950

Inclusion Criteria

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

Exclusion Criteria

• Parents not able to speak or write Swedish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child cognition as measured by Wechsler Preschool and Primary Scale of Intelligence	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.
Number of participants with food allergy	Outcome at six years	Food allergy
Number of participants with rhino-conjunctivitis	Outcome at six years	Rhino-conjunctivitis
Numbers of caries lesions (DeMFS = decayed, enamel included, missed, filled, tooth surfaces, in each child	Outcome at four years	Cariesfree individuals have a DeMFS = 0 and increasing scores means increasing degree of caries. Maximum DeMFS = 148, minumum DeMFS = 0.
Number of participants with excema	Outcome at six years	Excema
Number of participants with frhino-conjuctivitis	Outcome at one year	Rhino-conjunctivitis
Number of participants with asthma	Outcome at six years	Asthma

Trial Locations

Locations (1)

Sunderby Hospital; 🇸🇪 Luleå, Norrbotten County, Sweden