Immune TolerancePhase 4NCT01538485
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT
A Phase 4 study testing Cholecalciferol in people with Immune Tolerance, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Tolerance
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Aug 2012
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- non smoker
- BMI: 20-30 kg/m²
- Healthy
Who cannot join
- hypercalcemia > 2,65 mmol/L
- pregnancy
- chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
Read the detailed description
This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.
The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.
- Conditions
- Immune Tolerance
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D, regulatory T cells, GUT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Oleovit D3
weekly dose (based on 70IU KG body weight/day)
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Not described Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of regulatory FOXP3+ T cells
the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months
Measured: 2 months
Secondary outcomes (2)
other immune cells in the gastrointestinal mucosa
Measured: 2 months
serum calcium level
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ToleranceStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R. Pieber, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538485
- Sponsor's protocol ID
- ADPP 003: GUT
- Status last verified
- Oct 2012
- First submitted
- 8 Feb 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme
- ClinicalTrials.gov ID
- NCT01538485
- Acronym / sponsor ID
- ADPP 003: GUT
- Conditions
- Immune Tolerance
- Keywords
- Vitamin D, regulatory T cells, GUT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Feb 2012 (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.
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
Detailed description
This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.
The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-40 years
- non smoker
- BMI: 20-30 kg/m²
- Healthy
Key exclusion criteria (3 listed)
- hypercalcemia > 2,65 mmol/L
- pregnancy
- chronic diseases
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 |
|---|---|---|
| CholecalciferolAlso: Oleovit D3weekly dose (based on 70IU KG body weight/day) | Drug | Cholecalciferol |
Primary outcome
Increase of regulatory FOXP3+ T cells
Time frame: 2 months
the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months
2 secondary outcomes
other immune cells in the gastrointestinal mucosa
Time frame: 2 months
serum calcium level
Time frame: 2 months
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 10 Oct 2012.
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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.
Thomas R. Pieber, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Immune Tolerance, run by Medical University of Graz at 1 site in Austria.
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 4 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 10 Oct 2012. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Increase of regulatory FOXP3+ T cells (time frame: 2 months). 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 10 Oct 2012.