A Cross-sectional Study of Endocrine Changes in Children With Wilson's Disease at Assiut University Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- prevalence of endocrine dysfunction in pediatric Wilson's disease
研究概览
简要总结
This cross-sectional study investigates endocrine changes in children diagnosed with Wilson's disease, aiming to characterize hormonal dysfunctions affecting pituitary, thyroid, adrenal, and gonadal axes.
详细描述
Wilson's disease (WD) is an inherited copper metabolism disorder leading to copper accumulation in various organs including endocrine glands. While hepatic and neurological effects are well-documented, endocrine manifestations remain insufficiently studied in children. This study will systematically assess hormonal axes-including pituitary, growth hormone, thyroid, adrenal, and gonadal functions-through clinical evaluation, pubertal staging, and biochemical tests. The study aims to measure the prevalence and spectrum of endocrine abnormalities in pediatric WD patients and correlate them with disease severity and therapy. Findings will highlight underrecognized complications that impact growth, puberty, and fertility, contributing to more comprehensive management of WD in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-18 years
- •Confirmed diagnosis of Wilson's disease (based on clinical features, biochemical markers such as serum ceruloplasmin and 24-hour urinary copper)
- •Both newly diagnosed and treated patients (chelation/zinc therapy)
- •Informed consent from parents or guardians
排除标准
- •Congenital or acquired endocrine disorders unrelated to WD (e.g., congenital hypothyroidism, pituitary tumors)
- •Concurrent use of medications affecting hormonal function unless prescribed for WD (steroids, thyroid replacements, contraceptives)
- •Chronic systemic illnesses that confound endocrine assessment (e.g., malignancy, chronic renal failure)
结局指标
主要结局
prevalence of endocrine dysfunction in pediatric Wilson's disease
时间窗: baseline
Identification and classification of hormonal abnormalities affecting pituitary, adrenal, thyroid, and gonadal axes at study enrollment
次要结局
未报告次要终点
研究者
Alaa Atef Ahmed Sayed
resident at the Pediatrics Department, Hepatology Unit, Assiut University Children's Hospital
Assiut University