Celiac Disease in ChildrenCeliaQLifeNCT06568263
Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
An observational study of Celiac Disease in Children and Nutritional Deficiency, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Nutritional Deficiency, Quality of Life
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- 12 Aug 2024to 20 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Age: 6-18 years
Who may be able to join
- eating a regular diet
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0372
Cathrine Aa Strandskogen, MSc, 004791121290, cathrine.strandskogen@medisin.uio.no
Janne A Kvammen, PhD, 004793234722, uxjaam@ous-hf.no
- Recruiting
University of Oslo
Oslo, 0372
Christine Henriksen, Phd, 004799003128, christine.henriksen@medisin.uio.no
Cathrine Aa Strandskogen, MSc, 004791121290, cathrine.strandskogen@medisin.uio.no
About this study
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.
Read the 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.
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiac disease | Children diagnosed with celiac disease on a gluten-free diet | |
| Healthy | Healthy children on a regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All participants will be assessed once. The study time frame is from August 2024 until December 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start12 Aug 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Janne Anita Kvammen, PhD, Oslo University Hospital
- Investigators
- Janne A Kvammen, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568263
- Sponsor's protocol ID
- 591377
- Acronym
- CeliaQLife
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
- ClinicalTrials.gov ID
- NCT06568263
- Acronym / sponsor ID
- CeliaQLife / 591377
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac disease | – | –Children diagnosed with celiac disease on a gluten-free diet |
| Healthy | – | –Healthy children on a regular diet |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Age: 6-18 years
Key inclusion criteria (1 listed)
- eating a regular diet
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne A Kvammen, Phd principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Nutritional Deficiency, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathrine Aa Strandskogen, MSc (004791121290, cathrine.strandskogen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.