PLUTO: Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

• Sponsor: Scotmann Pharmaceuticals (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05104970
• Collaborator: Rawalpindi Medical College (Other)
• Enrollment: 60
• Arms: 4
• Anticipated Duration (Months): 6.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Drug: SunnyD insta ampoule; Dietary Supplement: SunnyD STAT softgel capsule; Drug: Placebo SunnyD insta ampoule; Dietary Supplement: Placebo SunnyD STAT softgel capsule	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: double blinded placebo controlled
• Primary Purpose: Treatment
• Official Title: Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
• Anticipated Study Start Date: Aug 9, 2022
• Anticipated Primary Completion Date: Jan 9, 2023
• Anticipated Study Completion Date: Feb 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Scotmann Pharmaceuticals
• Rawalpindi Medical College

Investigators

• Principal Investigator: Muhammad Umar, MBBS,FCPS, Rawalpindi Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scotmann Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05104970
• Other Study ID Numbers: SunnyD
• First Posted: Nov 3, 2021
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Scotmann Pharmaceuticals: Vitamin D
• Additional relevant MeSH terms: Vitamin D Deficiency

Study Results

No Results Posted as of May 26, 2022