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

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.

Recruiting

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Key information

Conditions

Celiac Disease in Children Malnutrition Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Quality of Life

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

eating a regular diet

Exclusion criteria

Treatment and study plan

Primary outcomes

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.

Blood samples will be analyzed for blood hemoglobin and serum ferritin.

Study contacts

Contact information is provided by the study sponsor or research team.

Cathrine Aa Strandskogen, MSc

CONTACT

[email protected]

004791121290

Janne A Kvammen, Phd

CONTACT

[email protected]

004793234722

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

University of Oslo

Registry information

Acronym: CeliaQLife

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 23, 2024
Registry last updated: Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed