Vitamin D Receptor Target Gene ExpressionPhase 1VitDHiDNCT03537027
Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 on Transcriptomic Changes of Low Vitamin D Responders
A Phase 1 study testing Vitamin D3 in people with Vitamin D Receptor Target Gene Expression and Serum 25(OH)D Concentration, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Receptor Target Gene Expression, Serum 25(OH)D Concentration
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 3 May 2018to 31 May 2018
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- BMI 20-25 kg/m2.
Who cannot join
- History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis.
- Continuous use of anti-inflammatory medicines.
- Regular use of supplements containing over 20 micrograms of vitamin D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 Treatment on Changes of the Transcriptome of Low Vitamin D Responders
The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.
Read the detailed description
Serum 25-hydroxyvitamin D3 [25(OH)D3] is a well-established marker for vitamin D status of the human body. In addition to the general importance of vitamin D for bone health, low serum 25(OH)D3 concentrations have been associated with increased risk of several health outcomes, such as autoimmune diseases, type 2 diabetes and cardiovascular complications. However, there is significant inter-individual variation in the average serum 25(OH)D3 concentrations and also in the response to supplementation with vitamin D. Genetic and epigenetic factors have been suggested to be responsible for a large part of the variation, but currently there is little information about the health effects of the variation.
In our previous studies VitDmet (Clinicaltrials.gov NCT01479933) and VitDbol (Clinicaltrials.gov NCT02063334) we showed that the participants can be classified into high, mid and low responders to vitamin D and defined the new biomarker "vitamin D response index". Some 25% of the population seem to be low responders and are under higher risk to suffer from insufficient supplementation with vitamin D. The current study will focus on low vitamin D responders (among the 40 healthy individuals recruited in the study, 20-60 years old), i.e. it will use the same oral vitamin D3 bolus (2,000 µg, i.e. 80,000 IU in one day) as in our VitDbol study, in order to identify low vitamin D responders.
By in vitro treatment of peripheral blood mononuclear cells (PBMCs) of low responders with 25(OH)D3 for 24 h (in comparison to in vitro stimulations with 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] and in vivo vitamin D3 supplementation of the same subjects) we will obtain samples that allow the transcriptome-wide investigation of changes in gene expression. The underlying hypothesis of this study is that a stimulation with 25(OH)D3 is more efficient than a treatment with vitamin D3, so that in future low vitamin D responders may be supplemented with 25(OH)D3 rather than with vitamin D3.
- Being tested
- Vitamin D3
- Keywords
- vitamin D3, cholecalciferol, calcidiol, 25-hydroxyvitamin D, gene expression, vitamin D receptor, adults, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
In total 20 pills will be taken by the subjects, each containing 100 micrograms of vitamin D3, resulting in the total amount of 2000 micrograms of vitamin D3. Of the 20 pills, 10 will be taken in the morning with breakfast and 10 with lunch.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | 2000 micrograms of vitamin D3 in two doses during one day Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo change from baseline in vitamin D target gene expression in the subjects
Effect of 2000 microgram vitamin D3 dose on the expression of vitamin D receptor target genes
Measured: 24 hours after the baseline
In vitro change from baseline in vitamin D target gene expression in peripheral blood mononuclear cells
Effects of treatment of cells for 24 h with 100 nM of 25(OH)D3, 1 nM of 1,25(OH)2D3 or vehicle (solvent) on the expression of vitamin D receptor target genes
Measured: 24 hours after the baseline
Secondary outcomes (5)
In vivo change from baseline in serum 25(OH)D concentration
Effect of 2000 microgram vitamin D3 dose on serum 25(OH)D3 concentrations
Measured: 24 hours after the baseline
In vivo change from baseline in serum calcium concentration (safety and tolerability)
Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum calcium concentrations
Measured: 24 hours after the baseline
In vivo change from baseline in serum alanine transaminase concentration (safety and tolerability)
Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum alanine transaminase (ALAT) concentrations
Measured: 24 hours after the baseline
In vivo change from baseline in serum gamma-glutamyl transferase concentration (safety and tolerability)
Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum gamma-glutamyl transferase (GGT) concentrations
Measured: 24 hours after the baseline
In vivo change from baseline in serum creatinine concentration (safety and tolerability)
Effect of 2000 microgram vitamin D3 dose on in vivo changes in serum creatinine concentrations
Measured: 24 hours after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start3 May 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D Receptor Target Gene ExpressionStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Carsten Carlberg, University of Eastern Finland
- Investigators
- Carsten Carlberg, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537027
- Sponsor's protocol ID
- VitDHiD
- Acronym
- VitDHiD
- Status last verified
- Oct 2018
- First submitted
- 26 Apr 2018
- Last updated
- 12 Oct 2018
- 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 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 Treatment on Changes of the Transcriptome of Low Vitamin D Responders
- ClinicalTrials.gov ID
- NCT03537027
- Acronym / sponsor ID
- VitDHiD / VitDHiD
- Keywords
- vitamin D3, cholecalciferol, calcidiol, 25-hydroxyvitamin D, gene expression, vitamin D receptor, adults, clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 3 May 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 25 May 2018 (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 purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.
Detailed description
Serum 25-hydroxyvitamin D3 [25(OH)D3] is a well-established marker for vitamin D status of the human body. In addition to the general importance of vitamin D for bone health, low serum 25(OH)D3 concentrations have been associated with increased risk of several health outcomes, such as autoimmune diseases, type 2 diabetes and cardiovascular complications. However, there is significant inter-individual variation in the average serum 25(OH)D3 concentrations and also in the response to supplementation with vitamin D. Genetic and epigenetic factors have been suggested to be responsible for a large part of the variation, but currently there is little information about the health effects of the variation.
In our previous studies VitDmet (Clinicaltrials.gov NCT01479933) and VitDbol (Clinicaltrials.gov NCT02063334) we showed that the participants can be classified into high, mid and low responders to vitamin D and defined the new biomarker "vitamin D response index". Some 25% of the population seem to be low responders and are under higher risk to suffer from insufficient supplementation with vitamin D. The current study will focus on low vitamin D responders (among the 40 healthy individuals recruited in the study, 20-60 years old), i.e. it will use the same oral vitamin D3 bolus (2,000 µg, i.e. 80,000 IU in one day) as in our VitDbol study, in order to identify low vitamin D responders.
By in vitro treatment of peripheral blood mononuclear cells (PBMCs) of low responders with 25(OH)D3 for 24 h (in comparison to in vitro stimulations with 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] and in vivo vitamin D3 supplementation of the same subjects) we will obtain samples that allow the transcriptome-wide investigation of changes in gene expression. The underlying hypothesis of this study is that a stimulation with 25(OH)D3 is more efficient than a treatment with vitamin D3, so that in future low vitamin D responders may be supplemented with 25(OH)D3 rather than with vitamin D3.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D32000 micrograms of vitamin D3 in two doses during one day |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-smoking
- BMI 20-25 kg/m2.
Key exclusion criteria (3 listed)
- History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis.
- Continuous use of anti-inflammatory medicines.
- Regular use of supplements containing over 20 micrograms of vitamin D.
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 D3Also: cholecalciferolIn total 20 pills will be taken by the subjects, each containing 100 micrograms of vitamin D3, resulting in the total amount of 2000 micrograms of vitamin D3. Of the 20 pills, 10 will be taken in the morning with breakfast and 10 with lunch. | Dietary supplement | Vitamin D3 |
Primary outcome
In vivo change from baseline in vitamin D target gene expression in the subjects
Time frame: 24 hours after the baseline
Effect of 2000 microgram vitamin D3 dose on the expression of vitamin D receptor target genes
In vitro change from baseline in vitamin D target gene expression in peripheral blood mononuclear cells
Time frame: 24 hours after the baseline
Effects of treatment of cells for 24 h with 100 nM of 25(OH)D3, 1 nM of 1,25(OH)2D3 or vehicle (solvent) on the expression of vitamin D receptor target genes
5 secondary outcomes
In vivo change from baseline in serum 25(OH)D concentration
Time frame: 24 hours after the baseline
In vivo change from baseline in serum calcium concentration (safety and tolerability)
Time frame: 24 hours after the baseline
In vivo change from baseline in serum alanine transaminase concentration (safety and tolerability)
Time frame: 24 hours after the baseline
In vivo change from baseline in serum gamma-glutamyl transferase concentration (safety and tolerability)
Time frame: 24 hours after the baseline
In vivo change from baseline in serum creatinine concentration (safety and tolerability)
Time frame: 24 hours after the baseline
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 12 Oct 2018.
- 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.
Carsten Carlberg, PhD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 in people with Vitamin D Receptor Target Gene Expression and Serum 25(OH)D Concentration, run by University of Eastern Finland at 1 site in Finland.
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 3 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 12 Oct 2018. 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 Finland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
In vivo change from baseline in vitamin D target gene expression in the subjects (time frame: 24 hours after the baseline). 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?
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 12 Oct 2018.