Healthy HumansPhase 4NCT01248442
Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
A Phase 4 study testing Cholecalciferol in people with Healthy Humans, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Humans
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2009to Jun 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >= 10 years
- healthy subjects without chronic disease
Who cannot join
- Hypercalcemia >2,65 mmol/L
- pregnancy and lactation period
- acute infections
- chronic disease requiring treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.
In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.
Read the detailed description
This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.
The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.
Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.
- Conditions
- Healthy Humans
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Vitamin D Deficiency, Autoimmune disease, Diabetes
- Medical subject headings
- Vitamin D Deficiency, Autoimmune Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Oleovit D3
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
PlaceboDrug
Also called Almondoil
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Not described Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase and function of peripheral regulatory T-cells
The level and function of the regulatory T-cells will be compared between the two groups.
Measured: 3 months
Secondary outcomes (4)
immunophenotyping
The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.
Measured: 3 months
Renin and aldosterone concentrations
serum renin and aldosterone levels will be measured basal and after 3 months.
Measured: 3 months
Insulin secretion
Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months
Measured: 3 months
calcium levels
serum calcium levels will be measured basal and monthly for 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJun 2010
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 Healthy HumansStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT01248442
- Sponsor's protocol ID
- ENM-EA-011
- Status last verified
- Feb 2012
- First submitted
- 24 Nov 2010
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prietl B, Treiber G, Mader JK, Hoeller E, Wolf M, Pilz S, Graninger WB, Obermayer-Pietsch BM, Pieber TR. High-dose cholecalciferol supplementation significantly increases peripheral CD4(+) Tregs in healthy adults without negatively affecting the frequency of other immune cells. Eur J Nutr. 2014 Apr;53(3):751-9. doi: 10.1007/s00394-013-0579-6. Epub 2013 Sep 3.
PubMed 23999998
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.
- ClinicalTrials.gov ID
- NCT01248442
- Acronym / sponsor ID
- ENM-EA-011
- Conditions
- Healthy Humans
- Keywords
- Vitamin D Deficiency, Autoimmune disease, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Nov 2010 (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 placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.
Detailed description
This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.
The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.
Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Drug: Cholecalciferol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 10 years
- healthy subjects without chronic disease
Key exclusion criteria (4 listed)
- Hypercalcemia >2,65 mmol/L
- pregnancy and lactation period
- acute infections
- chronic disease requiring treatment
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 D3monthly dose of 140.000 IU of cholecalciferol orally, 3 times. | Drug | Cholecalciferol |
| PlaceboAlso: AlmondoilMatching Placebo | Drug | Placebo |
Primary outcome
Increase and function of peripheral regulatory T-cells
Time frame: 3 months
The level and function of the regulatory T-cells will be compared between the two groups.
4 secondary outcomes
immunophenotyping
Time frame: 3 months
Renin and aldosterone concentrations
Time frame: 3 months
Insulin secretion
Time frame: 3 months
calcium levels
Time frame: 3 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 9 Feb 2012.
- Derived from this study: PubMed 23999998Prietl B, Treiber G, Mader JK, Hoeller E, Wolf M, Pilz S, Graninger WB, Obermayer-Pietsch BM, Pieber TR. High-dose cholecalciferol supplementation significantly increases peripheral CD4(+) Tregs in healthy adults without negatively affecting the frequency of other immune cells. Eur J Nutr. 2014 Apr;53(3):751-9. doi: 10.1007/s00394-013-0579-6. Epub 2013 Sep 3.
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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 Healthy Humans, 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 2 inclusion and 4 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 9 Feb 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. 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 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 and function of peripheral regulatory T-cells (time frame: 3 months). 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 NCT01248442, 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 9 Feb 2012.