Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Phase 2

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: SunnyD STAT softgel capsule; Drug: SunnyD insta ampoule; Dietary Supplement: Placebo SunnyD STAT softgel capsule; Drug: Placebo SunnyD insta ampoule

• Registration Number: NCT05104970
• Lead Sponsor: Scotmann Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-21
• Last Update Posted: 2022-05-26
• Study Start: 2022-08-09
• Primary Completion: 2023-01-09
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SunnyD STAT softgel capsule	SunnyD STAT softgel capsule	Cholecalciferol 200000 IU
SunnyD insta ampoule	SunnyD insta ampoule	Vitamin D3 200000 IU
Placebo SunnyD STAT softgel capsule	Placebo SunnyD STAT softgel capsule	Olive oil only
Placebo SunnyD insta ampoule	Placebo SunnyD insta ampoule	Olive oil only

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	70 days	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

Secondary Outcome Measures

Name	Time	Method
Serum 25(OH)D level	3 months	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