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
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
- 否
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
cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)
干预措施: Cholecalciferol sequential dose (Drug)
Cholecalciferol daily dose
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
