Type 2 DiabetesPhase 2NCT00400491
Vitamin D Supplementation to Patients With Type 2 Diabetes
A Phase 2 study testing Cholecalciferol (vitamin D) in people with Type 2 Diabetes, run by University of Tromso at 1 site in Norway.
Trial summary
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cholecalciferol (vitamin D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2006to Sep 2007
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least 1 year
- age 21-75 years
- long-acting insulin at bedtime
- metformin during the day
- for women of child bearing age use of reliable method of birth control
Who cannot join
- serum creatinine above 130 umol/l for men and above 110 for women
- systolic blood pressure > 175 or diastolic > 104 mmHg
- heart disease
- serum calcium > 2.54 mmol/l
- history of renal stones
Trial locations and contacts
1 site in 1 country.
Norway1 site
Clinical Research Unit, University Hospital of North Norway
Tromsø, Tromsø, 9038
About this study
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
Read the detailed description
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.
- Conditions
- Type 2 Diabetes
- Being tested
- Cholecalciferol (vitamin D), Placebo
- Keywords
- diabetes, insulin, glycated hemoglobin, cholecalciferol, vitamin D
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (vitamin D)Drug
Also called vitamin D
Cholecalciferol capsule 20.000 IU twice per week for 6 months
PlaceboDrug
Placebo capsule twice a week, identical to the cholecalciferol capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cholecalciferol (vitamin D) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Measured: 6 months
Secondary outcomes (6)
blood pressure
Measured: 6 months
body weight
Measured: 6 months
Hip/waist ratio
Measured: 6 months
lipids
Measured: 6 months
Hs-CRP
Measured: 6 months
insulin sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Investigators
- Rolf Jorde, Professor, Principal investigator, University of Tromsø, Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400491
- Sponsor's protocol ID
- EUDRACT-2006-000177-30
- Status last verified
- May 2008
- First submitted
- 16 Nov 2006
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation to Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00400491
- Acronym / sponsor ID
- EUDRACT-2006-000177-30
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, insulin, glycated hemoglobin, cholecalciferol, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Nov 2006 (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 the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
Detailed description
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cholecalciferol (vitamin D) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes for at least 1 year
- age 21-75 years
- long-acting insulin at bedtime
- metformin during the day
- for women of child bearing age use of reliable method of birth control
Key exclusion criteria (5 listed)
- serum creatinine above 130 umol/l for men and above 110 for women
- systolic blood pressure > 175 or diastolic > 104 mmHg
- heart disease
- serum calcium > 2.54 mmol/l
- history of renal stones
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 |
|---|---|---|
| Cholecalciferol (vitamin D)Also: vitamin DCholecalciferol capsule 20.000 IU twice per week for 6 months | Drug | 1 |
| PlaceboPlacebo capsule twice a week, identical to the cholecalciferol capsules | Drug | 2 |
Primary outcome
glycated hemoglobin
Time frame: 6 months
6 secondary outcomes
blood pressure
Time frame: 6 months
body weight
Time frame: 6 months
Hip/waist ratio
Time frame: 6 months
lipids
Time frame: 6 months
Hs-CRP
Time frame: 6 months
insulin sensitivity
Time frame: 6 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 23 May 2008.
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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.
Rolf Jorde, Professor principal investigator
University of Tromsø, Tromsø
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 Cholecalciferol (vitamin D) in people with Type 2 Diabetes, run by University of Tromso at 1 site in Norway.
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 5 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 23 May 2008. 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 Norway. 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.
What does the primary outcome measure?
glycated hemoglobin (time frame: 6 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 23 May 2008.