Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: SunnyD insta ampoule
* Dietary Supplement: SunnyD STAT softgel capsule
* Drug: Placebo SunnyD insta ampoule
* Dietary Supplement: Placebo SunnyD STAT softgel capsule


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Adult (20-70 years of age) Vitamin D deficiency (serum 25(OH)D < 20 ng/ml) Permanent employees of Medicine ward of Holy Family Hospital, DHQ, BBH hospitals and RMU for easy follow up throughout the study duration Willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed EXCLUSION CRITERIA: Vitamin D sufficiency or moderate deficiency (serum 25(OH)D > 20 ng/ml) Pregnant ladies Participants already taking Vitamin D supplementation, anti-convulsants, barbiturates or steroids Subjects with granulomatous conditions, liver disease, kidney disease, or diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SunnyD STAT softgel capsule<br>Cholecalciferol 200000 IU | Dietary Supplement: SunnyD STAT softgel capsule<br>* Cholecalciferol 200000 IU softgel capsule<br>|
| Placebo Comparator: Placebo SunnyD STAT softgel capsule<br>Olive oil only | Dietary Supplement: Placebo SunnyD STAT softgel capsule<br>* Olive oil<br>|
| Active Comparator: SunnyD insta ampoule<br>Vitamin D3 200000 IU | Drug: SunnyD insta ampoule<br>* Cholecalciferol 200000 IU insta ampoule<br>|
| Placebo Comparator: Placebo SunnyD insta ampoule<br>Olive oil only | Drug: Placebo SunnyD insta ampoule<br>* Olive oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D