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

NCT06568263 | Recruiting

• 1 other identifier: 591377
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Celiac Disease in Children; Nutritional Deficiency; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

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

  All participants will be assessed once. The study time frame is from August 2024 until December 2025.

Study Arms (2)

Celiac disease

Children diagnosed with celiac disease on a gluten-free diet

Healthy

Healthy children on a regular diet

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Age: 6-18 years

You may qualify if:

• eating a regular diet

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

University of Oslo

Oslo, 0372, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine and feces

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Janne A Kvammen, Phd

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathrine Aa Strandskogen, MSc

CONTACT

004791121290; cathrine.strandskogen@medisin.uio.no

Janne A Kvammen, Phd

CONTACT

004793234722; uxjaam@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 23, 2024
• Study Start: August 12, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

NO (2)