Vitamin D Supplementation in Children and Adolescents Seen in the Paediatric Nephrology Service: Study of the Efficacy of Service Usual Care (Cholecalciferol) and Its Impact on Calciuria.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Efficacy of usual vitamin D supplementation
研究概览
简要总结
Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection).
Until recently, vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20 nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency.
Recommendations for Vit D supplementation in healthy children were updated in France in 2012. The invariable supplementation of infants and toddlers is efficient since deficiency-related rickets have almost disappeared; however there is very few information in ill children populations.
Vit D supplementation tolerance is usually considered as good and over-dosage risks are low, however these studies were conducted more than 30 years ago, and as far as we know, there is no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL, which is very rare in daily practice, toxic effects of Vit D may theoretically be observed, particularly hypercalcemia and hypercalciuria.
Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to 92% prevalence depending on the studies; it it is a risk factor for secondary hyperparathyroidism.
Although international guidelines regarding the care of CKD children recommend 25 OH vitamin D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of dose and frequency of native Vit D treatment.
Therefore, the objectives of the present study has are the following:
- to validate prospectively the efficacy of our service usual care for Vit D supplementation of children and adolescents seen in the paediatric nephrology department.
- and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on calciuria in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : between [18 mo et 18 yo[
- •Patients seen in the paediatric nephrology service and having :
- •Chronic kidney disease
- •Renal transplant
- •Stable nephrotic syndrome (i.e., normal protidemia at inclusion)
- •Initial 25 OH vitamin D concentration < 75nmol/l
- •Patient agree to participate (if old enough to give his agreement) and written informed consent signed by parents
- •Patients affiliated within the French universal healthcare system
排除标准
- •- Contraindication to 100 000 IU Uvedose® treatment (according to the Summary of Product Characteristics: known hypersensitivity to vitamin D or hypercalcemia, hypercalciuria or nephrolithiasis).
研究组 & 干预措施
Usual vitamin D supplementation
干预措施: Cholecalciferol vial (100 000 UI) (Drug)
结局指标
主要结局
Efficacy of usual vitamin D supplementation
时间窗: Day 60
The 25 OH vitamin D serum concentration will be measured at inclusion (before treatment intake) and 2 months after supplementation. No extra blood intake is programmed since this parameter is always measured in this population. The main evaluation criterion is defined as a 25 OH vitamin D serum concentration over 75 nmol/l at month 2. This defines the success of supplementation. The failure is defined as a 25 OH vitamin D serum concentration under 75 nmol/l at month 2.
次要结局
- Kinetics of calciuria after a 100 000 IU vial of cholecalciferol(Day 0, day 1, day 2, day 3, day 4, day 7 after treatment intake.)