Vitamin D DeficiencyPhase 2PLUTONCT05104970
Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
A Phase 2 study testing SunnyD insta ampoule and SunnyD STAT softgel capsule in people with Vitamin D Deficiency, run by Scotmann Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- SunnyD insta ampoule and SunnyD STAT softgel capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2022to 10 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- SunnyD insta ampoule, SunnyD STAT softgel capsule, Placebo SunnyD insta ampoule, Placebo SunnyD STAT softgel capsule
- Keywords
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunnyD insta ampouleDrug
Cholecalciferol 200000 IU insta ampoule
SunnyD STAT softgel capsuleDietary supplement
Cholecalciferol 200000 IU softgel capsule
Placebo SunnyD insta ampouleDrug
Olive oil
Placebo SunnyD STAT softgel capsuleDietary supplement
Olive oil
| Study group | Role | What they receive |
|---|---|---|
| SunnyD STAT softgel capsule | Active comparator | Cholecalciferol 200000 IU Receives: Dietary Supplement: SunnyD STAT softgel capsule |
| Placebo SunnyD STAT softgel capsule | Placebo comparator | Olive oil only Receives: Dietary Supplement: Placebo SunnyD STAT softgel capsule |
| SunnyD insta ampoule | Active comparator | Vitamin D3 200000 IU Receives: Drug: SunnyD insta ampoule |
| Placebo SunnyD insta ampoule | Placebo comparator | Olive oil only Receives: Drug: Placebo SunnyD insta ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 70 days
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start9 Aug 2022 (estimated)
- Primary completion9 Jan 2023 (estimated)
- Study completion10 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scotmann Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College
- Responsible party
- Sponsor
- Investigators
- Muhammad Umar, MBBS,FCPS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104970
- Sponsor's protocol ID
- SunnyD
- Acronym
- PLUTO
- Status last verified
- May 2022
- First submitted
- 26 Oct 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proforma
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
- ClinicalTrials.gov ID
- NCT05104970
- Acronym / sponsor ID
- PLUTO / SunnyD
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Scotmann PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College
- Study start
- 9 Aug 2022 (estimated)
- Primary completion
- 9 Jan 2023 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SunnyD STAT softgel capsule | Active comparator | Dietary Supplement: SunnyD STAT softgel capsuleCholecalciferol 200000 IU |
| Placebo SunnyD STAT softgel capsule | Placebo comparator | Dietary Supplement: Placebo SunnyD STAT softgel capsuleOlive oil only |
| SunnyD insta ampoule | Active comparator | Drug: SunnyD insta ampouleVitamin D3 200000 IU |
| Placebo SunnyD insta ampoule | Placebo comparator | Drug: Placebo SunnyD insta ampouleOlive oil only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunnyD insta ampouleCholecalciferol 200000 IU insta ampoule | Drug | SunnyD insta ampoule |
| SunnyD STAT softgel capsuleCholecalciferol 200000 IU softgel capsule | Dietary supplement | SunnyD STAT softgel capsule |
| Placebo SunnyD insta ampouleOlive oil | Drug | Placebo SunnyD insta ampoule |
| Placebo SunnyD STAT softgel capsuleOlive oil | Dietary supplement | Placebo SunnyD STAT softgel capsule |
Primary outcome
Area Under Curve (AUC)
Time frame: 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
1 secondary outcome
Serum 25(OH)D level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No. Proforma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Umar, MBBS,FCPS principal investigator
Rawalpindi Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SunnyD insta ampoule and SunnyD STAT softgel capsule in people with Vitamin D Deficiency, run by Scotmann Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syeda Saba Aslam, MBBS, MPH (00923136674333, syedasabaaslam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) (time frame: 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.