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.
Overview
- Phase
- Phase 2
- Intervention
- 50.000 IU vitamin D3 (Biodal 50,000 IU)
- Conditions
- Vitamin D Deficiency
- Sponsor
- Hayat Pharmaceutical Co. PLC
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 11 years ago
Overview
Brief Summary
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 .
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
intervention group
The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks
Intervention: 50.000 IU vitamin D3 (Biodal 50,000 IU)
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
Intervention: Placebo (to mimic Biodal 50,000 IU)
Outcomes
Primary Outcomes
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.
Time Frame: 14 weeks
To assess the dose regimen effectiveness used in this study as per Biodal SmPC.
Secondary Outcomes
- 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)