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

• Sponsor: Umeå University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05809479
• Collaborator: Göteborg University (Other), Chalmers University of Technology (Other), Karolinska Institutet (Other), Region Norrbotten (Other), The Swedish Research Council (Other), Forte (Industry), The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) (Other)
• Enrollment: 1,950
• Location: 1
• Anticipated Duration (Months): 180
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Diseases in Children	Other: No intervention

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 Design

• Study Type: Observational
• Actual Enrollment: 1950 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment
• Actual Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2030

Outcome Measures

Primary Outcome Measures

1. Number of participants with excema [Outcome at one year]

   Excema

2. Number of participants with food allergy [Outcome at one year]

   Food allergy

3. Number of participants with frhino-conjuctivitis [Outcome at one year]

   Rhino-conjunctivitis

4. Number of participants with asthma [Outcome at one year]

   Asthma

5. Number of participants with excema [Outcome at four years]

   Excema

6. Number of participants with food allergy [Outcome at four years]

   Food allergy

7. Number of participants with rhino-conjunctivitis [Outcome at four years]

   Rhino-conjuctivitis

8. Number of participants with asthma [Outcome at four years]

   Asthma

9. Number of participants with excema [Outcome at six years]

   Excema

10. Number of participants with food allergy [Outcome at six years]

    Food allergy

11. Number of participants with rhino-conjunctivitis [Outcome at six years]

    Rhino-conjunctivitis

12. Number of participants with asthma [Outcome at six years]

    Asthma

13. 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.

14. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Parents not able to speak or write Swedish

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunderby Hospital	Luleå	Norrbotten County	Sweden	97180

Sponsors and Collaborators

• Umeå University
• 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)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Umeå University
• ClinicalTrials.gov Identifier: NCT05809479
• Other Study ID Numbers: Dnr 2013-18-31M
• First Posted: Apr 12, 2023
• Last Update Posted: Apr 12, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Disease

Study Results

No Results Posted as of Apr 12, 2023