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

Recruiting

• Conditions: Celiac Disease in Children; Quality of Life; Nutritional Deficiency

• Registration Number: NCT06568263
• Lead Sponsor: Oslo University Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-12
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• eating a regular diet

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	All participants will be assessed once. The study time frame is from August 2024 until December 2025.	Blood samples will be analyzed for blood hemoglobin and serum ferritin.

Trial Locations

Locations (2)

Oslo University Hospital; 🇳🇴 Oslo, Norway

University of Oslo; 🇳🇴 Oslo, Norway