Chronic Diseases in ChildrenNICENCT05809479
NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment
An observational study of Chronic Diseases in Children, run by Umeå University at 1 site in Sweden.
Trial summary
Role of the exposome on allergy, caries, and neurophysiological development in childhood. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases in Children
- How many people
- 1,950 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 650 families (mother/father/child).
Who may be able to join
- Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018
Who cannot join
- Parents not able to speak or write Swedish
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Diseases in Children
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with excema
Excema
Measured: Outcome at one year
Number of participants with food allergy
Food allergy
Measured: Outcome at one year
Number of participants with frhino-conjuctivitis
Rhino-conjunctivitis
Measured: Outcome at one year
Number of participants with asthma
Asthma
Measured: Outcome at one year
Number of participants with excema
Excema
Measured: Outcome at four years
Number of participants with food allergy
Food allergy
Measured: Outcome at four years
Number of participants with rhino-conjunctivitis
Rhino-conjuctivitis
Measured: Outcome at four years
Number of participants with asthma
Asthma
Measured: Outcome at four years
Number of participants with excema
Excema
Measured: Outcome at six years
Number of participants with food allergy
Food allergy
Measured: Outcome at six years
Number of participants with rhino-conjunctivitis
Rhino-conjunctivitis
Measured: Outcome at six years
Number of participants with asthma
Asthma
Measured: Outcome at six years
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.
Measured: Outcome at four years
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.
Measured: Outcome at four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study startJun 2015
- Primary completionJun 2024 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Diseases in ChildrenStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Anna Sandin, Ass Prof, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809479
- Sponsor's protocol ID
- Dnr 2013-18-31M
- Acronym
- NICE
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stravik M, Sandin A, Hesselmar B, Wold AE, Barman M, Sandberg AS. Food introduction during the first year of life in a Swedish birth cohort - associations with allergy at 6 years of age. Nutr J. 2026 Jun 17;25(1):66. doi: 10.1186/s12937-026-01344-4.
PubMed 42310634Stravik M, Mayer Labba IC, Barman M, Svard L, Scheers N, Sandin A, Wold AE, Sandberg AS. Longitudinal Plasma Ferritin in the First Year of Life in Relation to Maternal Status, Birth Characteristics, and Breastfeeding. Nutrients. 2026 May 22;18(11):1657. doi: 10.3390/nu18111657.
PubMed 42280303
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment
- ClinicalTrials.gov ID
- NCT05809479
- Acronym / sponsor ID
- NICE / Dnr 2013-18-31M
- Conditions
- Chronic Diseases in Children
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,950 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- 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)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 650 families (mother/father/child).
Key inclusion criteria (1 listed)
- Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018
Key exclusion criteria (1 listed)
- Parents not able to speak or write Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Number of participants with excema
Time frame: Outcome at one year
Excema
Number of participants with food allergy
Time frame: Outcome at one year
Food allergy
Number of participants with frhino-conjuctivitis
Time frame: Outcome at one year
Rhino-conjunctivitis
Number of participants with asthma
Time frame: Outcome at one year
Asthma
Number of participants with excema
Time frame: Outcome at four years
Excema
Number of participants with food allergy
Time frame: Outcome at four years
Food allergy
Number of participants with rhino-conjunctivitis
Time frame: Outcome at four years
Rhino-conjuctivitis
Number of participants with asthma
Time frame: Outcome at four years
Asthma
Number of participants with excema
Time frame: Outcome at six years
Excema
Number of participants with food allergy
Time frame: Outcome at six years
Food allergy
Number of participants with rhino-conjunctivitis
Time frame: Outcome at six years
Rhino-conjunctivitis
Number of participants with asthma
Time frame: Outcome at six years
Asthma
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 42310634Stravik M, Sandin A, Hesselmar B, Wold AE, Barman M, Sandberg AS. Food introduction during the first year of life in a Swedish birth cohort - associations with allergy at 6 years of age. Nutr J. 2026 Jun 17;25(1):66. doi: 10.1186/s12937-026-01344-4.
- Derived from this study: PubMed 42280303Stravik M, Mayer Labba IC, Barman M, Svard L, Scheers N, Sandin A, Wold AE, Sandberg AS. Longitudinal Plasma Ferritin in the First Year of Life in Relation to Maternal Status, Birth Characteristics, and Breastfeeding. Nutrients. 2026 May 22;18(11):1657. doi: 10.3390/nu18111657.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Sandin, Ass Prof principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diseases in Children, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with excema (time frame: Outcome at one year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.