跳至主要内容
临床试验/NCT02975492
NCT02975492招募中不适用

Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2017年12月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
280
试验地点
1
主要终点
Changes from calcium level in urines at day 7, day 14 and day 28

研究概览

简要总结

Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

入选标准

  • Children aged 2 to 17 years included
  • Obtaining informed consent of the parents signed
  • Participants aged 18 years included

排除标准

  • 未提供

研究组 & 干预措施

Cholecalciferol sequential dose

Experimental

cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)

干预措施: Cholecalciferol sequential dose (Drug)

Cholecalciferol daily dose

Experimental

cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)

干预措施: Cholecalciferol daily dose (Drug)

结局指标

主要结局

Changes from calcium level in urines at day 7, day 14 and day 28

时间窗: day 7, day 14 and day 28

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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