Vitamin D Receptor Target Gene ExpressionPhase 1VitDbolNCT02063334
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
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 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 18 years and olderHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2014to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 vitamin D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)
The purpose of the study is to investigate 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 the detailed description
Serum 25-hydroxyvitamin D [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 study (VitDmet, Clinicaltrials.gov NCT01479933) we showed that only half of the participants responded to the 5-month vitamin D3 supplementation of 40 µg/day or 80 µg/day as expected and that certain vitamin D receptor (VDR) target genes were suitable biomarkers for displaying the transcriptomic response of human tissues to vitamin D3 supplementation.
The purpose of the current study is to investigate whether a high-dose vitamin D3 oral bolus produces marked VDR target gene expression response and whether there is large inter-individual variation, as what was suggested with the 5-month lower-dose supplementation.
In the Trial 1, the subjects are randomized to receive either 2,000 micrograms (80 000 IU) of vitamin D3 (n=20) or placebo (n=10) in one day. Blood samples are collected for peripheral blood mononuclear cell isolation and serum 25(OH)D3 measurements at baseline and 24 h and 48 h and 30 days after the first dose. Blood samples are also collected for immunomarker analyses. In the Trial 2, the procedures of the Trial 1 are repeated in two subjects with known low and high serum 25(OH)D3 concentrations in order to investigate more specifically the impact of different starting levels of serum 25(OH)D3.
In February 2015, new subjects were recruited to enter the Trial 1 in order to increase the size of the study. All the new subjects received the 2,000 microgram bolus of vitamin D3, there were no new subjects in the placebo arm.
June 30, 2016. Change to protocol: There will be no Trial 2, but instead the blood samples obtained in the Trial 1 from up to six subjects will be used for the additional analyses. The subjects are selected based on the response to vitamin D supplementation in the Trial 1.
- Being tested
- Vitamin D3, Placebo
- Keywords
- vitamin D3, cholecalciferol, calcidiol, 25-hydroxyvitamin D, gene expression, vitamin D receptor, randomized controlled trial, men, adults
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
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 25 pills will be taken by the subjects, each containing 80 micrograms of vitamin D3 or placebo. Of the 25 pills, 13 will be taken in the morning with breakfast and 12 with lunch.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | 2000 micrograms of vitamin D3 in two doses during one day Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Placebo in two doses during one day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vitamin D target gene expression
Effect of 2000 microgram vitamin D3 dose or placebo on the expression of vitamin D receptor target genes
Measured: 24 h, 48 h, and 30 days after the baseline
Secondary outcomes (1)
Change from baseline in serum 25(OH)D
Effect of 2000 microgram vitamin D3 dose or placebo on serum 25(OH)D3 concentrations
Measured: 24 h, 48 h, and 30 days 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 posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJun 2015
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyrki K Virtanen, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063334
- Sponsor's protocol ID
- VitDbol
- Acronym
- VitDbol
- Status last verified
- Jun 2016
- First submitted
- 4 Feb 2014
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Seuter S, Virtanen JK, Nurmi T, Pihlajamaki J, Mursu J, Voutilainen S, Tuomainen TP, Neme A, Carlberg C. Molecular evaluation of vitamin D responsiveness of healthy young adults. J Steroid Biochem Mol Biol. 2017 Nov;174:314-321. doi: 10.1016/j.jsbmb.2016.06.003. Epub 2016 Jun 6.
PubMed 27282116
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)
- ClinicalTrials.gov ID
- NCT02063334
- Acronym / sponsor ID
- VitDbol / VitDbol
- Keywords
- vitamin D3, cholecalciferol, calcidiol, 25-hydroxyvitamin D, gene expression, vitamin D receptor, randomized controlled trial, men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- 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 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.
Detailed description
Serum 25-hydroxyvitamin D [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 study (VitDmet, Clinicaltrials.gov NCT01479933) we showed that only half of the participants responded to the 5-month vitamin D3 supplementation of 40 µg/day or 80 µg/day as expected and that certain vitamin D receptor (VDR) target genes were suitable biomarkers for displaying the transcriptomic response of human tissues to vitamin D3 supplementation.
The purpose of the current study is to investigate whether a high-dose vitamin D3 oral bolus produces marked VDR target gene expression response and whether there is large inter-individual variation, as what was suggested with the 5-month lower-dose supplementation.
In the Trial 1, the subjects are randomized to receive either 2,000 micrograms (80 000 IU) of vitamin D3 (n=20) or placebo (n=10) in one day. Blood samples are collected for peripheral blood mononuclear cell isolation and serum 25(OH)D3 measurements at baseline and 24 h and 48 h and 30 days after the first dose. Blood samples are also collected for immunomarker analyses. In the Trial 2, the procedures of the Trial 1 are repeated in two subjects with known low and high serum 25(OH)D3 concentrations in order to investigate more specifically the impact of different starting levels of serum 25(OH)D3.
In February 2015, new subjects were recruited to enter the Trial 1 in order to increase the size of the study. All the new subjects received the 2,000 microgram bolus of vitamin D3, there were no new subjects in the placebo arm.
June 30, 2016. Change to protocol: There will be no Trial 2, but instead the blood samples obtained in the Trial 1 from up to six subjects will be used for the additional analyses. The subjects are selected based on the response to vitamin D supplementation in the Trial 1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D32000 micrograms of vitamin D3 in two doses during one day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo in two doses during one day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 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 25 pills will be taken by the subjects, each containing 80 micrograms of vitamin D3 or placebo. Of the 25 pills, 13 will be taken in the morning with breakfast and 12 with lunch. | Dietary supplement | Vitamin D3 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in vitamin D target gene expression
Time frame: 24 h, 48 h, and 30 days after the baseline
Effect of 2000 microgram vitamin D3 dose or placebo on the expression of vitamin D receptor target genes
1 secondary outcome
Change from baseline in serum 25(OH)D
Time frame: 24 h, 48 h, and 30 days 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 29 Jul 2016.
- Derived from this study: PubMed 27282116Seuter S, Virtanen JK, Nurmi T, Pihlajamaki J, Mursu J, Voutilainen S, Tuomainen TP, Neme A, Carlberg C. Molecular evaluation of vitamin D responsiveness of healthy young adults. J Steroid Biochem Mol Biol. 2017 Nov;174:314-321. doi: 10.1016/j.jsbmb.2016.06.003. Epub 2016 Jun 6.
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.
Jyrki K Virtanen, 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 29 Jul 2016. 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. 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 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?
Change from baseline in vitamin D target gene expression (time frame: 24 h, 48 h, and 30 days after the baseline). 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 NCT02063334, 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 29 Jul 2016.