NCT05675280已完成不适用
The Association Between Iron Deficiency at Diagnosis, Female Sex and Tissue Transglutaminase Antibody Normalization in Pediatric Celiac Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- TTG normalization
研究概览
简要总结
The investigators conducted a retrospective, observational cohort study which enrolled CD subjects aged 2-18y, diagnosed between Jan 2016 and Dec 2020. Demographic and laboratory data were collected at diagnosis and 1y after adherence to GFD. ID was determined according to hemoglobin and ferritin levels. The investigators compared CD subjects with and without ID at CD diagnosis in relation to TTG normalization at 1y.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (male and female) diagnosed with CD
- •Age 2-18y
排除标准
- •Total IgA deficiency
- •Anemia due to other causes - anyone with anemia and normal or elevated ferritin levels (e.g. thalassemia, spherocytosis)
- •Other chronic conditions increasing the risk of anemia or falsely elevated ferritin (e.g. inflammatory bowel disease, chronic kidney disease, infection)
结局指标
主要结局
TTG normalization
时间窗: 1 year from gluten free diet initiation
normalization of tissue transglutaminase antibody
次要结局
未报告次要终点
研究者
eyal zifman
Head of pediatric gastroenterology service
Meir Medical Center
研究点 (1)
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