Diabetes Mellitus, Type 2Phase 4EVIDENSNCT01497132
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
A Phase 4 study testing Vitamin D3 in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency
- 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
- 44 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to May 2013
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
- BMI ≤ 32 kg/m2.
- HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
- Fasting plasma glucose < 9 mmol/l
- S-25-OH-vitamin D3 < 75 nmol/l.
Who cannot join
- Treatment with any vitamin D preparation.
- Regular sun-bathing in solarium.
- Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
- Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
- Sarcoidosis or other granulomatous disease.
- Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
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- Impaired hepatic function.
- Impaired renal function
- Cardiac disease defined as:
- Unstable angina pectoris
- Myocardial infarction within the last 6 months
- Congestive heart failure NYHA class III and IV
- Cerebral stroke within the last 6 months.
- Anti-diabetic medication of any kind.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dpt of Endocrinology, Karolinska University Hospital
Stockholm, Stockholm County, 17176
About this study
Official title: Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vigantol oil
Oral drops 30000 IU weekly
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Not described Receives: Drug: Vitamin D3 |
| 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.
Beta cell function
Assessed by hyperglycemic clamp investigation
Measured: 8 weeks
Secondary outcomes (3)
Insulin sensitivity
Assessed by hyperglycemic clamp investigation
Measured: 8 weeks
Glucose tolerance
Assessed by OGTT
Measured: 8 weeks
Hypercalcemia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Wagner, Karolinska Institutet
- Investigators
- Henrik Wagner, M.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497132
- Sponsor's protocol ID
- DvitamininDM2_v1_110815
- Other IDs
- 2010-024487-18
- Acronym
- EVIDENS
- Status last verified
- Sep 2014
- First submitted
- 20 Dec 2011
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.
PubMed 26786573Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.
PubMed 25835492
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS
- ClinicalTrials.gov ID
- NCT01497132
- Acronym / sponsor ID
- EVIDENS / DvitamininDM2_v1_110815
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Dec 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.
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
- BMI ≤ 32 kg/m2.
- HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
- Fasting plasma glucose < 9 mmol/l
- S-25-OH-vitamin D3 < 75 nmol/l.
Key exclusion criteria (15 listed)
- Treatment with any vitamin D preparation.
- Regular sun-bathing in solarium.
- Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
- Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
- Sarcoidosis or other granulomatous disease.
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: Vigantol oilOral drops 30000 IU weekly | Drug | Vitamin D3 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Beta cell function
Time frame: 8 weeks
Assessed by hyperglycemic clamp investigation
3 secondary outcomes
Insulin sensitivity
Time frame: 8 weeks
Glucose tolerance
Time frame: 8 weeks
Hypercalcemia
Time frame: 8 weeks
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 Sep 2014.
- Derived from this study: PubMed 26786573Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.
- Derived from this study: PubMed 25835492Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.
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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.
Henrik Wagner, M.D principal investigator
Karolinska Institutet
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 Vitamin D3 in people with Diabetes Mellitus, Type 2 and Glucose Intolerance, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 15 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 Sep 2014. 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 Sweden. 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?
Beta cell function (time frame: 8 weeks). 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 NCT01497132, which also lists 2 linked publications.
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 Sep 2014.