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| Name | Class |
|---|---|
| Rawalpindi Medical College | OTHER |
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The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.
Deficiency of Vitamin D is highly prevalent in all sectors and regions of Pakistan. Its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. Health care workers are routinely prescribing supplementations to correct the deficiencies. Different forms of Cholecalciferol are available in the market. It ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. Different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SunnyD STAT softgel capsule | Active Comparator | Cholecalciferol 200000 IU |
|
| Placebo SunnyD STAT softgel capsule | Placebo Comparator | Olive oil only |
|
| SunnyD insta ampoule | Active Comparator | Vitamin D3 200000 IU |
|
| Placebo SunnyD insta ampoule | Placebo Comparator | Olive oil only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SunnyD insta ampoule | Drug | Cholecalciferol 200000 IU insta ampoule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | Area Under Curve (AUC) trail follow-up at 0,1,7,28,70. Trapezoidal method for calculations would be used and levels would be reported from lab essay of 25(OH)D | 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25(OH)D level | Serum 25(OH)D level would be checked at the end of the trial after 3 months to assess the change in levels (if any). It would be assessed through laboratory essay | 3 months |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syeda Saba Aslam, MBBS, MPH | Contact | 00923136674333 | syedasabaaslam@gmail.com | |
| Fazlur Rehman, MBBS,FCPS | Contact | 00923005226950 | lonsa25@student.london.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Umar, MBBS,FCPS | Rawalpindi Medical College | Principal Investigator |
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Proforma
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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double blinded placebo controlled
| SunnyD STAT softgel capsule |
| Dietary Supplement |
Cholecalciferol 200000 IU softgel capsule |
|
| Placebo SunnyD insta ampoule | Drug | Olive oil |
|
| Placebo SunnyD STAT softgel capsule | Dietary Supplement | Olive oil |
|
| D009750 |
| Nutritional and Metabolic Diseases |