Bioavailability of Vitamin DNCT06010121
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
A study testing Liposomal Vitamin D and Traditional Vitamin D in people with Bioavailability of Vitamin D, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial summary
The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bioavailability of Vitamin D
- What is being tested?
- Liposomal Vitamin D and Traditional Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePoland
- Study dates
- 17 Feb 2023to 6 Jun 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women and men, 18-60 years old.
- Signed informed consent.
- No injuries or hospitalizations within the last 3 months.
- No vitamin D supplementation for the 2 months prior to the study initiation.
- Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
- Refraining for the period of the clinical trial from the use of cosmetic therapies that use prolonged body illumination
Who cannot join
- Unwilling to give consent
- Injuries within the last 3 months
- Obesity, BMI above 30
- Bariatric surgery
- Cystic fibrosis, celiac disease, Crohn's disease
- Metabolic diseases
- Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids, anticonvulsants, calcium-containing preparations,
- Planned prolonged exposure to sunlight during the study period
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.
Read the detailed description
The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.
- Conditions
- Bioavailability of Vitamin D
- Being tested
- Liposomal Vitamin D, Traditional Vitamin D
- Keywords
- Liposovit-D, Vitamin D, Cholecalciferol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Vitamin DDietary supplement
2000 IU of cholecalciferol in liposomal formulation
Traditional Vitamin DDietary supplement
2000 IU of cholecalciferol in traditional formulation
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Vitamin D | Experimental | Daily oral dose of liposomal vitamin D for 4 weeks Receives: Dietary Supplement: Liposomal Vitamin D |
| Traditional Vitamin D | Active comparator | Daily oral dose of traditional vitamin D for 4 weeks Receives: Dietary Supplement: Traditional Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of 25-hydroxycholecalciferol
Comparison of the level of 25(OH)D3 achieved in the blood
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start17 Feb 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Vitamin DStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010121
- Sponsor's protocol ID
- 02-AP-VD
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
- ClinicalTrials.gov ID
- NCT06010121
- Acronym / sponsor ID
- 02-AP-VD
- Conditions
- Bioavailability of Vitamin D
- Keywords
- Liposovit-D, Vitamin D, Cholecalciferol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 24 Aug 2023 (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 the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.
Detailed description
The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Vitamin D | Experimental | Dietary Supplement: Liposomal Vitamin DDaily oral dose of liposomal vitamin D for 4 weeks |
| Traditional Vitamin D | Active comparator | Dietary Supplement: Traditional Vitamin DDaily oral dose of traditional vitamin D for 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women and men, 18-60 years old.
- Signed informed consent.
- No injuries or hospitalizations within the last 3 months.
- No vitamin D supplementation for the 2 months prior to the study initiation.
- Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
Key exclusion criteria (8 listed)
- Unwilling to give consent
- Injuries within the last 3 months
- Obesity, BMI above 30
- Bariatric surgery
- Cystic fibrosis, celiac disease, Crohn's disease
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 |
|---|---|---|
| Liposomal Vitamin D2000 IU of cholecalciferol in liposomal formulation | Dietary supplement | Liposomal Vitamin D |
| Traditional Vitamin D2000 IU of cholecalciferol in traditional formulation | Dietary supplement | Traditional Vitamin D |
Primary outcome
Level of 25-hydroxycholecalciferol
Time frame: Baseline, 2 weeks, 4 weeks
Comparison of the level of 25(OH)D3 achieved in the blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Vitamin D and Traditional Vitamin D in people with Bioavailability of Vitamin D, run by AronPharma Sp. z o. o. at 1 site in Poland.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of 25-hydroxycholecalciferol (time frame: Baseline, 2 weeks, 4 weeks). 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 25 Aug 2023.