EUCTR2018-000508-40-HU进行中（未招募）1 期
Controlled randomized open label clinical study to compare the efficacy and the safety of the loading dose schedules of Vitamin D3 (colecalciferol) 30,000 IU product in deficient patients - The efficacy and the safety of Vitamin D3 30,000 IU for loading dose schedules
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Trial subjects are in 18-70 years of age.
- •2.25(OH)D levels not above of 16 ng/ml by the inclusion
- •3.Female subjects are under efficient contraception or in postmenopause.
- •4.The trial subject has the willingness to comply with study procedures and to give voluntary written informed consent signed and dated prior to enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Sever uncontrolled metabolic disease or endocrine disease
- •2.Significant obesity (BMI> 36)
- •3.Increased serum calcium level seCa >2.60 mmol/l results or symptoms of hypercalcemia in last year
- •4.Persistent hypercalciuria or signs of kidney stone in last one year
- •5.Sever kidney diseases (CKD 3 or higher)
- •6.Chronic or serious disease, which can significantly influence the absorption, metabolism of bones or vitamin D or Ca
- •7.Significant absorption disorders that may abolish Ca intake
- •8.Heart failure or angina pectoris.
- •9.Signs or suspected alcohol or drug abuse
- •10.More than 1000 IU per day vitamin D intake within 2 month prior to trial (in any forms medication, or nutritional food supplement)
- •11.Existence or suspected gravidity
- •12.Any other finding or symptoms which may indicate a potential interference with the safety by the opinion of the Investigator
- •13.Has been exposed to any investigational agent within 3 months prior the enrolment to the study
- •14.Planned travel (>4 days) to a region with high UVB exposure or regular (>2 /month) use of UVB exposition (e.g.solarium)
- •15.Concomitant medication which is not allowed:
- •glycosides
- •Magnesium-containing preparations (antacids)
- •cholestyramine and other ion exchange resins, orlistat
- •thiazide diuretics
- •regular use of microsomal enzyme inducers (anticonvulsants, sedatives, etc.).
- •corticosteroids (except for dermatological use)
- •products containing phosphorus
- •regular use of laxatives (such as paraffin oil)
- •drugs affecting inhibition on lipid absorption
研究者
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