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Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol (PLUTO)

Primary Purpose

Vitamin D Deficiency

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SunnyD insta ampoule

SunnyD STAT softgel capsule

Placebo SunnyD insta ampoule

Placebo SunnyD STAT softgel capsule

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

SunnyD STAT softgel capsule

Placebo SunnyD STAT softgel capsule

SunnyD insta ampoule

Placebo SunnyD insta ampoule

Arm Description

Cholecalciferol 200000 IU

Olive oil only

Vitamin D3 200000 IU

Olive oil only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05104970

First Posted

October 26, 2021

Last Updated

May 21, 2022

Sponsor

Scotmann Pharmaceuticals

Collaborators

Rawalpindi Medical College

1. Study Identification

Unique Protocol Identification Number

NCT05104970

Brief Title

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Acronym

PLUTO

Official Title

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 9, 2022 (Anticipated)

Primary Completion Date

January 9, 2023 (Anticipated)

Study Completion Date

February 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Scotmann Pharmaceuticals

Collaborators

Rawalpindi Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

double blinded placebo controlled

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SunnyD STAT softgel capsule

Arm Type

Active Comparator

Arm Description

Cholecalciferol 200000 IU

Arm Title

Placebo SunnyD STAT softgel capsule

Arm Type

Placebo Comparator

Arm Description

Olive oil only

Arm Title

SunnyD insta ampoule

Arm Type

Active Comparator

Arm Description

Vitamin D3 200000 IU

Arm Title

Placebo SunnyD insta ampoule

Arm Type

Placebo Comparator

Arm Description

Olive oil only

Intervention Type

Drug

Intervention Name(s)

SunnyD insta ampoule

Intervention Description

Cholecalciferol 200000 IU insta ampoule

Intervention Type

Dietary Supplement

Intervention Name(s)

SunnyD STAT softgel capsule

Intervention Description

Cholecalciferol 200000 IU softgel capsule

Intervention Type

Drug

Intervention Name(s)

Placebo SunnyD insta ampoule

Intervention Description

Olive oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo SunnyD STAT softgel capsule

Intervention Description

Olive oil

Primary Outcome Measure Information:

Title

Area Under Curve (AUC)

Description

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

Time Frame

70 days

Secondary Outcome Measure Information:

Title

Serum 25(OH)D level

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Syeda Saba Aslam, MBBS, MPH

Phone

00923136674333

syedasabaaslam@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Fazlur Rehman, MBBS,FCPS

Phone

00923005226950

lonsa25@student.london.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Umar, MBBS,FCPS

Organizational Affiliation

Rawalpindi Medical College

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Proforma

Learn more about this trial

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

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