NCT06568263

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Celiac Disease in Children
• Nutritional Deficiency
• Quality of Life

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-12-20
• Completion: 2025-12-20
• First posted: 2024-08-23
• Last updated: 2024-08-23

Locations

2 sites across 1 country: Norway