Type 1 DiabetesPhase 4NCT01390480
Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
A Phase 4 study testing Cholecalciferol in people with Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- 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
- 31 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2010to Feb 2014
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- males or females > 6 years
- new onset of type 1 diabetes (3 months)
Who cannot join
- pregnancy
- hypercalcemia (>2,65 mmol/L)
- chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
Read the detailed description
This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.
- Conditions
- Type 1 Diabetes
- Being tested
- Cholecalciferol
- Keywords
- vitamin D, Autoimmune disease, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, 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 intervention: Oleovit D3, Placebo: peanut oil
weekly dose (based on 70 IU/kg bodyweight/day) orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | peanut oil Receives: Drug: Cholecalciferol |
| Vitamin D (Oleovit®) | Active comparator | cholecalciferol Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase and function of regulatory T-cells
The level and function of the regulatory T-cells will be compared between the two groups.
Measured: 13 months
Secondary outcomes (3)
Immunophenotyping
The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.
Measured: 13 months
Insulin secretion
Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.
Measured: 13 months
Calcium levels
Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionFeb 2014
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 Type 1 DiabetesStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Thomas Pieber, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390480
- Sponsor's protocol ID
- ENM-DA-017
- Status last verified
- Apr 2015
- First submitted
- 23 May 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Treiber G, Prietl B, Frohlich-Reiterer E, Lechner E, Ribitsch A, Fritsch M, Rami-Merhar B, Steigleder-Schweiger C, Graninger W, Borkenstein M, Pieber TR. Cholecalciferol supplementation improves suppressive capacity of regulatory T-cells in young patients with new-onset type 1 diabetes mellitus - A randomized clinical trial. Clin Immunol. 2015 Dec;161(2):217-24. doi: 10.1016/j.clim.2015.08.002. Epub 2015 Aug 12.
PubMed 26277548
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme
- ClinicalTrials.gov ID
- NCT01390480
- Acronym / sponsor ID
- ENM-DA-017
- Conditions
- Type 1 Diabetes
- Keywords
- vitamin D, Autoimmune disease, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Jul 2011 (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 effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
Detailed description
This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cholecalciferolpeanut oil |
| Vitamin D (Oleovit®) | Active comparator | Drug: Cholecalciferolcholecalciferol |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- males or females > 6 years
- new onset of type 1 diabetes (3 months)
Key exclusion criteria (3 listed)
- pregnancy
- hypercalcemia (>2,65 mmol/L)
- chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
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: intervention: Oleovit D3, Placebo: peanut oilweekly dose (based on 70 IU/kg bodyweight/day) orally | Drug | Placebo, Vitamin D (Oleovit®) |
Primary outcome
Increase and function of regulatory T-cells
Time frame: 13 months
The level and function of the regulatory T-cells will be compared between the two groups.
3 secondary outcomes
Immunophenotyping
Time frame: 13 months
Insulin secretion
Time frame: 13 months
Calcium levels
Time frame: 13 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 17 Apr 2015.
- Derived from this study: PubMed 26277548Treiber G, Prietl B, Frohlich-Reiterer E, Lechner E, Ribitsch A, Fritsch M, Rami-Merhar B, Steigleder-Schweiger C, Graninger W, Borkenstein M, Pieber TR. Cholecalciferol supplementation improves suppressive capacity of regulatory T-cells in young patients with new-onset type 1 diabetes mellitus - A randomized clinical trial. Clin Immunol. 2015 Dec;161(2):217-24. doi: 10.1016/j.clim.2015.08.002. Epub 2015 Aug 12.
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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 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 Type 1 Diabetes, 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 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 17 Apr 2015. 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 regulatory T-cells (time frame: 13 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 NCT01390480, 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 17 Apr 2015.