Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Celiac Disease in Children, Nutritional Deficiency, Quality of Life. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
* 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.
Primary outcome measures
- Iron deficiency will be assessed from hemoglobin and ferritin in children with celiac disease and in healthy children. Differences in the prevalences of iron deficiency between children with celiac disease and healthy children will be described. [Time frame: All participants will be assessed once. The study time frame is from August 2024 until December 2025.]
Eligibility criteria
Inclusion criteria
- eating a regular diet
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Norway · 2 centers
- Oslo University Hospital — Oslo
- University of Oslo — Oslo
Identifiers
NCT: NCT06568263 · 591377