Safety and Efficacy Evaluation of the Dose Regimen of Vitamin D 50,000 IU(Biodal) Tablet Supplementation in the Treatment of Population With Vitamin D Deficiency.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.
研究概览
简要总结
Abstract:
The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of population with vitamin D deficiency.
A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained are expected to assess the safety and efficacy of the dose regimen used in this study as per Biodal SmPC. This study will also contribute to the global body of knowledge in this field. The major findings generated from this study could open certain avenues for further research through the association of the status of vitamin D in serum .
详细描述
The study design will be a prospective randomized double blind parallel design comparing Vitamin D with Placebo. This study will be conducted in Jordan University Hospital (JUH). The participants will be Healthy males and females with vitamin D deficiency (18 to 49 years old). All eligible males and females who agree to participate in the study will sign an informed witnessed consent form at the beginning of the study. The expected duration of participants participation will be around 120 days and the number of visits for each participant will be 6 visits divided as follows; the first visit will be before 7 days of the initiation of the trial (screening period), the second on day zero of the treatment period, the third on day 30, the fourth on day 60, the fifth on day 90 and the sixth or the last visit will be on day 104 (after 14 days of the last treatment). Therefore the treatment period will be 90 days and the post treatment follow up period will be 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
intervention group
The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks
干预措施: 50.000 IU vitamin D3 (Biodal 50,000 IU) (Drug)
Placebo group
The placebo group will receive placebo Tablet which will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging
干预措施: Placebo (to mimic Biodal 50,000 IU) (Drug)
结局指标
主要结局
Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.
时间窗: 14 weeks
To assess the dose regimen effectiveness used in this study as per Biodal SmPC.
次要结局
- Assessing the level of (Urine analysis, Hematology ,Kidney Function Test,Liver Function Test, Virology, chemistry, 25(OH)D, Ca, Mg, Phosphate, Parathyroid hormone, Alkaline Phosphatase ) and reporting any adverse events through the trial period.(14 weeks)