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临床试验/NCT04694976
NCT04694976已完成不适用

Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Determination of 25-OH Vitamin D level

研究概览

简要总结

Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children: under 18 years old
  • Sickle cell any genetic type homozygous or composite heterozygous
  • To receive an assessment independently of the study, during a presentation to the emergency ward and/or a follow-up consultation by the hematologist
  • no parental opposition signed by at least one parent/legal representative and no child opposition
  • social security beneficiary

排除标准

  • History of hematologic grafting

结局指标

主要结局

Determination of 25-OH Vitamin D level

时间窗: Day 1

We classify vitamin D status as follows : * Sufficiency \> \>75nmol/L (\>30 ng/mL) * Insufficiency 50-75 nmol/L (20-30 ng/mL) * Deficiency 12-50nmol/L (5-20 ng/mL) * Severe deficiency \<12 nmol/L (\<5 ng/mL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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