Effectiveness of Vitamin D Supplementation in the Prevention of Vitamin D Deficiency in Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- serum 25-hydroxyvitamin D level
研究概览
简要总结
Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. The aim of the study is to assess the effectiveness of vitamin D supplementation in the prevention of vitamin D deficiency in Polish children (4-10 years of age).
详细描述
Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children.
Aims:
- Assessment of the impact of vitamin D intake at a dose of 1000 IU / day on vitamin D status in children aged 4-10 years.
- Evaluation of the effectiveness of supply of vitamin D at a dose of 1000 IU / day in preventing vitamin D deficiency and maintaining optimal vitamin D status ( 25OHD level >30ng/ml)
- Evaluation of vitamin D status depending on age, BMI and body composition.
- Assessing the safety and tolerability of mel ● tiki vitamin D in children. Material: Children aged 4-10 years Study desing: Prospective intervention trial Intervention: cholecalciferol at a dose 1000 IU/day for 3 months
Methods:
- Analysis of clinical characteristics (attendance at kindergarten / school, consumption of products rich in vitamin D, exposure to sun, use of sunblock's, the overall child's health (chronic diseases, medications, vitamins, micronutrients)
- Anthropometric measurements (body weight, height, BMI, assessment of body fat content - body composition by bioimpedance method- TANITA)
- Assessment of vitamin D status (serum total 25OHD concentration in blood serum by immunochemiluminescence method)
- Collecting data on the tolerability and safety of meliki ● tiki vitamin D including possible symptoms of vitamin D overdose
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent
排除标准
- •Osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial
研究组 & 干预措施
cholecalciferol
cholecalciferol at a dose 1000 IU /day for 3 months
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
serum 25-hydroxyvitamin D level
时间窗: during 3 months of vitamin D supplementation
after intervension vs baseline level
次要结局
- prevalence of vitamin D deficiency(during 3 months of vitamin D supplementation)
- prevalence of vitamin D suficiency(during 3 months of vitamin D supplementation)
研究者
Justyna Czech-Kowalska, Associate Professor
Deputy Head of Neonatal Department
Children's Memorial Health Institute, Poland