Type 1 DiabetesPhase 2NCT00960635
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
A Phase 2 study testing 1,25-dihydroxy-vitamin D3 (calcitriol) in people with Type 1 Diabetes, run by Institut fur Diabetesforschung, Munich, Germany at 1 site in Germany.
Trial summary
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 1,25-dihydroxy-vitamin D3 (calcitriol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jun 2001to Aug 2008
- Phase
- Phase 2
- 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 39 years
- All sexes
- Adult
Who may be able to join
- New onset Typ 1 diabetes (< 6 weeks insulin therapy)
- Age 18-39 years
- GADA and/or IA-2A positive
Who cannot join
- Kidney disease
- Pregnancy
- Lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.
- Conditions
- Type 1 Diabetes
- Being tested
- 1,25-dihydroxy-vitamin D3 (calcitriol), placebo
- Keywords
- new-onset
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,25-dihydroxy-vitamin D3 (calcitriol)Drug
placeboDrug
pill without agent
| Study group | Role | What they receive |
|---|---|---|
| calcitriol | Active comparator | Not described Receives: Drug: 1,25-dihydroxy-vitamin D3 (calcitriol) |
| pill without agent | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJun 2001
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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 2
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetesforschung, Munich, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Anette G Ziegler, MD, Principal investigator, Institut fuer Diabetesforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960635
- Sponsor's protocol ID
- 336/00
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.
PubMed 20357369
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00960635
- Acronym / sponsor ID
- 336/00
- Conditions
- Type 1 Diabetes
- Keywords
- new-onset
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institut fur Diabetesforschung, Munich, GermanyUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Aug 2009 (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.
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.
Study design
- Primary purpose
- Prevention
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcitriol | Active comparator | Drug: 1,25-dihydroxy-vitamin D3 (calcitriol) |
| pill without agent | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- New onset Typ 1 diabetes (< 6 weeks insulin therapy)
- Age 18-39 years
- GADA and/or IA-2A positive
Key exclusion criteria (3 listed)
- Kidney disease
- Pregnancy
- Lactating
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 |
|---|---|---|
| 1,25-dihydroxy-vitamin D3 (calcitriol) | Drug | calcitriol |
| placebopill without agent | Drug | pill without agent |
Primary outcome
Not reported in the source record.
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 18 Aug 2009.
- Derived from this study: PubMed 20357369Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.
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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.
Anette G Ziegler, MD principal investigator
Institut fuer Diabetesforschung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1,25-dihydroxy-vitamin D3 (calcitriol) in people with Type 1 Diabetes, run by Institut fur Diabetesforschung, Munich, Germany at 1 site in Germany.
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 3 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 18 Aug 2009. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960635, 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 18 Aug 2009.