Vitamin D Supplementation to Patients With Type 2 Diabetes
NCT ID: NCT00400491
Last Updated: 2008-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2006-06-30
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
2
Placebo
Placebo capsule twice a week, identical to the cholecalciferol capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
Placebo
Placebo capsule twice a week, identical to the cholecalciferol capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* systolic blood pressure \> 175 or diastolic \> 104 mmHg
* heart disease
* serum calcium \> 2.54 mmol/l
* history of renal stones
21 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tromso
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Tromso
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rolf Jorde, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Tromsø, Tromsø
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Unit, University Hospital of North Norway
Tromsø, Tromsø, Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT-2006-000177-30
Identifier Type: -
Identifier Source: org_study_id