Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
PLUTO
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2023
CompletedMay 26, 2022
May 1, 2022
5 months
October 26, 2021
May 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Serum 25(OH)D level
3 months
Study Arms (4)
SunnyD STAT softgel capsule
ACTIVE COMPARATORCholecalciferol 200000 IU
Placebo SunnyD STAT softgel capsule
PLACEBO COMPARATOROlive oil only
SunnyD insta ampoule
ACTIVE COMPARATORVitamin D3 200000 IU
Placebo SunnyD insta ampoule
PLACEBO COMPARATOROlive oil only
Interventions
Cholecalciferol 200000 IU softgel capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scotmann Pharmaceuticalslead
- Rawalpindi Medical Collegecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Umar, MBBS,FCPS
Rawalpindi Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- double blinded placebo controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 3, 2021
Study Start
August 9, 2022
Primary Completion
January 9, 2023
Study Completion
February 10, 2023
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
Proforma