DonneDVit : Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years. Randomized controlled trial with 2 parallel groups.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Occurrence of hypercalciuria beyond the lithogenic threshold for age. This will be assessed by measuring the calcium/creatinine ratio in mmol/mmol in the first morning urine sample collected during at least one of the three measurements taken on day 7, day 14, and day 28.
研究概览
简要总结
To evaluate the impact of the mode of vitamin D supplementation (high sequential dose or daily intake) on the incidence of hypercalciuria (urinary calcium/creatinine ratio) measured on day 7, day 14, and day 28 in Mediterranean subjects aged 2 to 18 years inclusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Period J28
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children aged 2 to 18 years included
- •Obtaining informed consent of the parents signed/the adult subject
- •Subjects covered by a social security scheme
排除标准
- •Subject who received a dose of vitamin D (80,000 or 100,000 units or more): Uvedose (Cholecalciferol) 5,000, 100,000 U, Zyma D 80,000 U (Cholecalciferol), 200,000 U, Stérogyl 15A or 15H (Ergocalciferol) within the three months prior to inclusion in the study
- •Subject treated with Uvesterol 5000 IU
- •Subject with a known condition that may affect calcium-phosphate metabolism: 1/ renal failure, chronic kidney disease, 2/endocrine disorder (thyroid, parathyroid, hypersensitivity to vitamin D, etc.), 3/ chronic liver and/or digestive disease, 4/congenital bone disease.
- •Subject receiving a treatment that induces hypercalciuria (systemic corticosteroids, diuretics)
- •Subject receiving calcium supplementation justified by a medical need
- •Subject with prolonged immobilization
- •Subject participating in another interventional research program.
结局指标
主要结局
Occurrence of hypercalciuria beyond the lithogenic threshold for age. This will be assessed by measuring the calcium/creatinine ratio in mmol/mmol in the first morning urine sample collected during at least one of the three measurements taken on day 7, day 14, and day 28.
Occurrence of hypercalciuria beyond the lithogenic threshold for age. This will be assessed by measuring the calcium/creatinine ratio in mmol/mmol in the first morning urine sample collected during at least one of the three measurements taken on day 7, day 14, and day 28.
次要结局
- Detection of calcium oxalate microcrystals in the first morning urine sample during at least one of the three crystalluria analyses conducted on day 7, day 14, and day 28.
- Evaluation of tolerance: systematic collection of expected and unexpected adverse events.
研究者
Pr MORIN Denis
Scientific
Centre Hospitalier Universitaire De Montpellier