- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209425
Pharmacokinetics Evaluation of Vitamin D Formulations
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia Solnier, Dr.
- Phone Number: +1 604-415-4185
- Email: jsolnier@factorsgroup.com
Study Locations
-
-
British Columbia
-
Coquitlam, British Columbia, Canada, V3K 6Y2
- Natural Factors
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Regular Vitamin D3 1000IU
The first group receives regular Vitamin D3 1000IU
|
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.
|
Active Comparator: Microencapsulated Vitamin D3 1000IU
The second group receives microencapsulated Vitamin D3 1000IU
|
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.
|
Active Comparator: Regular Vitamin D3 2500IU
The third group receives regular Vitamin D3 2500IU
|
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.
|
Active Comparator: Microencapsulated Vitamin D3 2500IU
The fourth group receives microencapsulated Vitamin D3 2500IU
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Venous blood samples are collected to measure concentrations of AST
|
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).
|
Venous blood samples are collected to measure concentrations of ALT
|
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).
|
Venous blood samples are collected to measure concentrations of alkaline phosphatase
|
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).
|
Venous blood samples are collected to measure concentrations of total bilirubin
|
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).
|
Venous blood samples are collected to measure concentrations of GGT
|
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).
|
Venous blood samples are collected to measure concentrations of creatinine
|
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).
|
Venous blood samples are collected to measure concentrations of CRP
|
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).
|
Venous blood samples are collected to measure concentrations of calcium
|
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).
|
Venous blood samples are collected to measure concentrations of magnesium
|
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).
|
Venous blood samples are collected to measure concentrations of phosphate
|
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).
|
Venous blood samples are collected to measure concentrations of sodium
|
at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-11-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D
-
University of UlsterNorthern Ireland Executive; HSC Public Health AgencyCompletedVitamin D Status | Vitamin D ConcentrationUnited Kingdom
-
Hospices Civils de LyonCompleted
-
Horopito LimitedAtlantia Food Clinical TrialsCompleted
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
University Hospital, Clermont-FerrandTerminated
-
Mike O'Callaghan Military HospitalWithdrawnVitamin DUnited States
-
King's College LondonVitamax Wholesalers LLPRecruiting
-
Boston UniversityPure North S'Energy FoundationCompletedVitamin D InsufficiencyUnited States
-
University of CopenhagenCompleted
-
Sheffield Children's NHS Foundation TrustCompleted
Clinical Trials on Vitamin D3
-
Aga Khan UniversityCompletedVitamin D DeficiencyPakistan
-
Medical University of South CarolinaThrasher Research FundCompletedVitamin D Deficiency | PregnancyUnited States
-
Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun Kharaa...CompletedVitamin D Deficiency | PregnancyMongolia
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute... and other collaboratorsCompletedHIV InfectionUnited States, Puerto Rico
-
Rutgers UniversityCompleted
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkCompletedMigraine According to International Headache Society (IHS) Criteria (ICHD-II)Denmark
-
Nationwide Children's HospitalOhio State UniversityUnknownVitamin D Deficiency | AsthmaUnited States
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Sanjay Gandhi Postgraduate Institute of Medical...CompletedPancreatitis, ChronicIndia
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting