Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568263
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Celiac Disease and Quality of Life in Children and Adolescents CeliaQLife
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Celiac Disease and Quality of Life in Children and Adolescents CeliaQLife
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CeliaQLife
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 childrens 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None