Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)

NCT ID: NCT06568263

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-12

Study Completion Date

2025-12-20

Brief Summary

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Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being.

The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children.

The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed.

The study can contribute to ensure good health and well-being in children on a gluten-free diet.

Detailed Description

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* A 24-hour dietary recall will be done by a clinical dietician to assess intake of energy and micro- and macronutrients.
* Blood will be drawn for assessment of vitamin- and mineral status.
* Feces and urine samples will be collected to measure gluten immunogenic peptides (GIP) to assess exposure to gluten.
* A self-developed interview will be used for assessment of adherence to the gluten-free diet and compared with the results from a 11-item questionnaire.
* Weight and height will be measured.
* Bone mineral density and body composition will be measured by dual-energy x-ray absorptiometry (DXA).
* Health-related quality of life (QOL) will be measured by the PedsQL.

Conditions

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Celiac Disease in Children Nutritional Deficiency Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Celiac disease

Children diagnosed with celiac disease on a gluten-free diet

No interventions assigned to this group

Healthy

Healthy children on a regular diet

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* eating a regular diet

Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Janne Anita Kvammen, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janne A Kvammen, Phd

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

University of Oslo

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Cathrine Aa Strandskogen, MSc

Role: CONTACT

004791121290

Janne A Kvammen, Phd

Role: CONTACT

004793234722

Facility Contacts

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Cathrine Aa Strandskogen, MSc

Role: primary

004791121290

Janne A Kvammen, PhD

Role: backup

004793234722

Christine Henriksen, Phd

Role: primary

004799003128

Cathrine Aa Strandskogen, MSc

Role: backup

004791121290

Other Identifiers

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591377

Identifier Type: -

Identifier Source: org_study_id

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