Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Vitamin D Deficiency Clinical Trial

— PLUTO  

Official title:

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05104970
• Other study ID #: SunnyD
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 9, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: May 2022
• Source: Scotmann Pharmaceuticals
• Contact: Syeda Saba Aslam, MBBS, MPH
• Phone: 00923136674333
• Email: syedasabaaslam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 10, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

INCLUSION CRITERIA:

1. Adult (20-70 years of age)

2. Vitamin D deficiency (serum 25(OH)D < 20 ng/ml)

3. Permanent employees of Medicine ward of Holy Family Hospital, DHQ, BBH hospitals and RMU for easy follow up throughout the study duration

4. Willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed

EXCLUSION CRITERIA:

1. Vitamin D sufficiency or moderate deficiency (serum 25(OH)D > 20 ng/ml)

2. Pregnant ladies

3. Participants already taking Vitamin D supplementation, anti-convulsants, barbiturates or steroids

4. Subjects with granulomatous conditions, liver disease, kidney disease, or diabetes

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• SunnyD insta ampoule
Cholecalciferol 200000 IU insta ampoule

Dietary Supplement:
• SunnyD STAT softgel capsule
Cholecalciferol 200000 IU softgel capsule

Drug:
• Placebo SunnyD insta ampoule
Olive oil

Dietary Supplement:
• Placebo SunnyD STAT softgel capsule
Olive oil

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Scotmann Pharmaceuticals	Rawalpindi Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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