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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Cathrine Aa Strandskogen, MSc; Phone Number: 004791121290; Email: cathrine.strandskogen@medisin.uio.no
• Study Contact Backup: Name: Janne A Kvammen, PhD; Phone Number: 004793234722; Email: uxjaam@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Recruiting
    • Oslo University Hospital
    • Contact: Cathrine Aa Strandskogen, MSc; Phone Number: 004791121290; Email: cathrine.strandskogen@medisin.uio.no
    • Contact: Janne A Kvammen, PhD; Phone Number: 004793234722; Email: uxjaam@ous-hf.no
    • Sub-Investigator: Ketil Størdal, PhD
  • Oslo, Norway, 0372
    • Recruiting
    • University of Oslo
    • Contact: Cathrine Aa Strandskogen, MSc; Phone Number: 004791121290; Email: cathrine.strandskogen@medisin.uio.no
    • Contact: Christine Henriksen, Phd; Phone Number: 004799003128; Email: christine.henriksen@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Age: 6-18 years

Description

Inclusion Criteria:

• eating a regular diet

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Celiac disease; Children diagnosed with celiac disease on a gluten-free diet
Healthy; Healthy children on a regular diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Janne A Kvammen, Phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease; Malnutrition
• Other Study ID Numbers: 591377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No