Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Phosphorus-calcium metabolism assessment
研究概览
简要总结
This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.
详细描述
This retrospective prospective interventional study will examine vitamin D availability and its relationship with clinical disease, patient gender and age, and season. The mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin D status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified diagnosis of epidermolysis bullosa;
- •Signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study
排除标准
- •not planned
研究组 & 干预措施
Group 1 - Vitamin D
Patients receiving vitamin D supplements in therapy
干预措施: Vitamin D (Drug)
Group 2 - Oral nutritional supplement
Patients receiving oral nutritional supplement
干预措施: Oral nutritional supplement (Dietary Supplement)
Group 3 - Vitamin D+Oral nutritional supplement
Patients receiving vitamin D supplements and oral nutritional supplement in therapy
干预措施: Vitamin D (Drug)
Group 3 - Vitamin D+Oral nutritional supplement
Patients receiving vitamin D supplements and oral nutritional supplement in therapy
干预措施: Oral nutritional supplement (Dietary Supplement)
结局指标
主要结局
Phosphorus-calcium metabolism assessment
时间窗: 24 week
Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood
Vitamin D level
时间窗: 24 week
Study of the provision of vitamin D in children with dystrophic and simple forms of epidermolysis bullosa based on the level of 25 (OH) vitamin D (25 hydroxycholecalciferol) in the blood
Assessment of the state of bone tissue
时间窗: 24 week
Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood
Assessment of indicators of physical development
时间窗: 24 wee
Z-score calculation (weight-for-height z-score)
次要结局
- Assessment of bone mineral density(24 week)
- Bone age assessment(24 week)