Vitamin DNCT05209425
Pharmacokinetics Evaluation of Vitamin D Formulations
A study testing Vitamin D3 in people with Vitamin D, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 30 Apr 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 21 and 65 years; avoid consumption of any additional food supplements containing vitamin D; avoid use of tanning beds or other artificial UVB sources.
- Participants must complete an online questionnaire on their medical history, weight, height, lifestyle (smoking, exercising etc.) and dietary habits relating to food rich in vitamin D, including other dietary supplementations.
Who cannot join
- use of vitamin D, calcium, magnesium, fish oil, or omega 3 fatty acids supplements; history of acute or chronic illness (such as gastrointestinal, liver and kidney disorders, osteoporosis …); pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics Evaluation of Different Vitamin D3 Formulations
The primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Pharmacokinetic parameters (Serum 25(OH)D and 1,25(OH)2D ng/ml) are compared with those of a regular Vitamin D formulation and a new (microencapsulated) LipoMicel Vitamin D formulation.
The secondary objective of this study is to evaluate safety blood parameters- The following blood parameters (serum levels) are checked: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. In addition, mineral levels-such as calcium, magnesium and phosphorus, potassium and sodium-are measured before and at the end of the study.
Read the detailed description
Study Design:
At least 40 healthy volunteers of both sexes in the age range 21-65 participate in a parallel, randomized blinded study conducted with different vitamin D3 products.
Each treatment is administered orally per day at a total dose of 1000 UI and 2500 IU vitamin d3 (cholecalciferol), together with breakfast, over a period of 30 days.
Participants are randomly divided into 4 groups (at least 10 per group):
The first group receives regular Vitamin D (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D (2500IU), the fourth receives microencapsulated D3 (2500 IU).
Plasma concentrations (serum levels) of Vitamin D (25(OH)D and 1,25(OH)2D ng/ml are measured at baseline-before treatment start (day 0), during treatment (day 5, 10 and 15; one blood collection per day) and at end of treatment (day 30).
After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60.
The entire study session will span the course of 60 days. Participants are asked to attend 7 visits at LifeLabs to collect venous blood samples.
Each Vitamin D treatment is consumed with a glass of water along with breakfast for a period of 30 days.
Safety blood work is performed upon study enrolment, at the end of the Vitamin supplementation (day 30)- and at the end of the study (day 60) at Life Labs.
The following blood parameters are checked and must be within normal ranges to participate the study: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT.
Mineral levels-such as calcium, magnesium and phosphorus-are measured before and at the end of the study (day 30).
All participants must understand written and spoken English and give written informed consent before any study specific procedure will be carried out.
All tested products are formulation manufactured by Factors Group.
- Conditions
- Vitamin D
- Being tested
- Vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Participants are randomly divided into 4 groups. The first group receives regular Vitamin D3 (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D3 (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations of Vitamin D (D3, 25(OH)D3 and D2) are measured at baseline-before treatment start (day 0), during treatment (day 14) and at end of treatment (day 30). After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60.
| Study group | Role | What they receive |
|---|---|---|
| Regular Vitamin D3 1000IU | Active comparator | The first group receives regular Vitamin D3 1000IU Receives: Dietary Supplement: Vitamin D3 |
| Microencapsulated Vitamin D3 1000IU | Active comparator | The second group receives microencapsulated Vitamin D3 1000IU Receives: Dietary Supplement: Vitamin D3 |
| Regular Vitamin D3 2500IU | Active comparator | The third group receives regular Vitamin D3 2500IU Receives: Dietary Supplement: Vitamin D3 |
| Microencapsulated Vitamin D3 2500IU | Active comparator | The fourth group receives microencapsulated Vitamin D3 2500IU Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D
Venous blood samples are collected to measure concentrations of 1,25-Dihydroxyvitamin D
Measured: at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D
Venous blood samples are collected to measure concentrations of 25-Hydroxyvitamin D
Measured: at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Secondary outcomes (11)
Safety blood work evaluation - change of aspartate aminotransferase (AST)
Venous blood samples are collected to measure concentrations of AST
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of alanine aminotransferase (ALT)
Venous blood samples are collected to measure concentrations of ALT
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of alkaline phosphatase
Venous blood samples are collected to measure concentrations of alkaline phosphatase
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of bilirubin
Venous blood samples are collected to measure concentrations of total bilirubin
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of gamma-glutamyl transferase (GGT)
Venous blood samples are collected to measure concentrations of GGT
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of creatinine
Venous blood samples are collected to measure concentrations of creatinine
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of C Reactive Protein (CRP)
Venous blood samples are collected to measure concentrations of CRP
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as calcium
Venous blood samples are collected to measure concentrations of calcium
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as magnesium
Venous blood samples are collected to measure concentrations of magnesium
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as phosphate
Venous blood samples are collected to measure concentrations of phosphate
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as sodium
Venous blood samples are collected to measure concentrations of sodium
Measured: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel, randomized blinded study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Factors Group of Nutritional Companies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209425
- Sponsor's protocol ID
- 2021-11-001
- Status last verified
- Sep 2023
- First submitted
- 20 Dec 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solnier J, Chang C, Zhang Y, Kuo YC, Du M, Roh YS, See J, Brix J, Gahler RJ, Green T, Wood S. A Comparison and Safety Evaluation of Micellar versus Standard Vitamin D3 Oral Supplementation in a Randomized, Double-Blind Human Pilot Study. Nutrients. 2024 May 22;16(11):1573. doi: 10.3390/nu16111573.
PubMed 38892507
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Evaluation of Different Vitamin D3 Formulations
- ClinicalTrials.gov ID
- NCT05209425
- Acronym / sponsor ID
- 2021-11-001
- Conditions
- Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Factors Group of Nutritional Companies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Jan 2022 (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 primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Pharmacokinetic parameters (Serum 25(OH)D and 1,25(OH)2D ng/ml) are compared with those of a regular Vitamin D formulation and a new (microencapsulated) LipoMicel Vitamin D formulation.
The secondary objective of this study is to evaluate safety blood parameters- The following blood parameters (serum levels) are checked: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. In addition, mineral levels-such as calcium, magnesium and phosphorus, potassium and sodium-are measured before and at the end of the study.
Detailed description
Study Design:
At least 40 healthy volunteers of both sexes in the age range 21-65 participate in a parallel, randomized blinded study conducted with different vitamin D3 products.
Each treatment is administered orally per day at a total dose of 1000 UI and 2500 IU vitamin d3 (cholecalciferol), together with breakfast, over a period of 30 days.
Participants are randomly divided into 4 groups (at least 10 per group):
The first group receives regular Vitamin D (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D (2500IU), the fourth receives microencapsulated D3 (2500 IU).
Plasma concentrations (serum levels) of Vitamin D (25(OH)D and 1,25(OH)2D ng/ml are measured at baseline-before treatment start (day 0), during treatment (day 5, 10 and 15; one blood collection per day) and at end of treatment (day 30).
After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60.
The entire study session will span the course of 60 days. Participants are asked to attend 7 visits at LifeLabs to collect venous blood samples.
Each Vitamin D treatment is consumed with a glass of water along with breakfast for a period of 30 days.
Safety blood work is performed upon study enrolment, at the end of the Vitamin supplementation (day 30)- and at the end of the study (day 60) at Life Labs.
The following blood parameters are checked and must be within normal ranges to participate the study: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT.
Mineral levels-such as calcium, magnesium and phosphorus-are measured before and at the end of the study (day 30).
All participants must understand written and spoken English and give written informed consent before any study specific procedure will be carried out.
All tested products are formulation manufactured by Factors Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- parallel, randomized blinded study
| Arm | Type | Receives |
|---|---|---|
| Regular Vitamin D3 1000IU | Active comparator | Dietary Supplement: Vitamin D3The first group receives regular Vitamin D3 1000IU |
| Microencapsulated Vitamin D3 1000IU | Active comparator | Dietary Supplement: Vitamin D3The second group receives microencapsulated Vitamin D3 1000IU |
| Regular Vitamin D3 2500IU | Active comparator | Dietary Supplement: Vitamin D3The third group receives regular Vitamin D3 2500IU |
| Microencapsulated Vitamin D3 2500IU | Active comparator | Dietary Supplement: Vitamin D3The fourth group receives microencapsulated Vitamin D3 2500IU |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 21 and 65 years; avoid consumption of any additional food supplements containing vitamin D; avoid use of tanning beds or other artificial UVB sources.
- Participants must complete an online questionnaire on their medical history, weight, height, lifestyle (smoking, exercising etc.) and dietary habits relating to food rich in vitamin D, including other dietary supplementations.
Key exclusion criteria (1 listed)
- use of vitamin D, calcium, magnesium, fish oil, or omega 3 fatty acids supplements; history of acute or chronic illness (such as gastrointestinal, liver and kidney disorders, osteoporosis …); pregnancy or lactation.
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 |
|---|---|---|
| Vitamin D3Participants are randomly divided into 4 groups. The first group receives regular Vitamin D3 (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D3 (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations of Vitamin D (D3, 25(OH)D3 and D2) are measured at baseline-before treatment start (day 0), during treatment (day 14) and at end of treatment (day 30). After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60. | Dietary supplement | Microencapsulated Vitamin D3 1000IU, Microencapsulated Vitamin D3 2500IU, Regular Vitamin D3 1000IU, Regular Vitamin D3 2500IU |
Primary outcome
Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D
Time frame: at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Venous blood samples are collected to measure concentrations of 1,25-Dihydroxyvitamin D
Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D
Time frame: at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).
Venous blood samples are collected to measure concentrations of 25-Hydroxyvitamin D
11 secondary outcomes
Safety blood work evaluation - change of aspartate aminotransferase (AST)
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of alanine aminotransferase (ALT)
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of alkaline phosphatase
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of bilirubin
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of gamma-glutamyl transferase (GGT)
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of creatinine
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of C Reactive Protein (CRP)
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as calcium
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as magnesium
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as phosphate
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
Safety blood work evaluation - change of mineral levels such as sodium
Time frame: at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
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 13 Sep 2023.
- Derived from this study: PubMed 38892507Solnier J, Chang C, Zhang Y, Kuo YC, Du M, Roh YS, See J, Brix J, Gahler RJ, Green T, Wood S. A Comparison and Safety Evaluation of Micellar versus Standard Vitamin D3 Oral Supplementation in a Randomized, Double-Blind Human Pilot Study. Nutrients. 2024 May 22;16(11):1573. doi: 10.3390/nu16111573.
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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.
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 Vitamin D3 in people with Vitamin D, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
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 2 inclusion and 1 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 13 Sep 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 Canada. 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?
Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D (time frame: at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209425, which also lists 1 linked publication.
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 13 Sep 2023.