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

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 Overview

• Status: Not yet recruiting
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: SunnyD STAT softgel capsule; Dietary supplement: Placebo SunnyD STAT softgel capsule; Drug: SunnyD insta ampoule; Drug: Placebo SunnyD insta ampoule

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Syeda Saba Aslam, MBBS, MPH; Phone Number: 00923136674333; Email: syedasabaaslam@gmail.com
• Study Contact Backup: Name: Fazlur Rehman, MBBS,FCPS; Phone Number: 00923005226950; Email: lonsa25@student.london.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SunnyD STAT softgel capsule; Cholecalciferol 200000 IU	Dietary supplement: SunnyD STAT softgel capsule; Cholecalciferol 200000 IU softgel capsule
Placebo Comparator: Placebo SunnyD STAT softgel capsule; Olive oil only	Dietary supplement: Placebo SunnyD STAT softgel capsule; Olive oil
Active Comparator: SunnyD insta ampoule; Vitamin D3 200000 IU	Drug: SunnyD insta ampoule; Cholecalciferol 200000 IU insta ampoule
Placebo Comparator: Placebo SunnyD insta ampoule; Olive oil only	Drug: Placebo SunnyD insta ampoule; Olive oil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Scotmann Pharmaceuticals
• Collaborators: Rawalpindi Medical College
• Investigators: Principal Investigator: Muhammad Umar, MBBS,FCPS, Rawalpindi Medical College

Study record dates

Study Major Dates

• Study Start (Anticipated): August 9, 2022
• Primary Completion (Anticipated): January 9, 2023
• Study Completion (Anticipated): February 10, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: SunnyD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Proforma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No