Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •eating a regular diet
排除标准
- 未提供
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Janne Anita Kvammen, PhD
Principal Investigator
Oslo University Hospital