| Trial ID: | L6933 |
| Source ID: | NCT00992797
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity
|
| Acronym: |
DIVINE
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2|Hypovitaminosis D
|
| Interventions: |
DRUG: Cholecalciferol|OTHER: Orange juice
|
| Outcome Measures: |
Primary: Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp, Before and after the 6 months intervention period | Secondary: Insulin secretion measured with IVGTT, At 0 and 6 months|Physical activity/muscle strength, At 0 and 6 months|HbA1c and fasting glucose, At 0, 3 and 6 months|Arterial stiffness, At 0 and 6 months|Differences in inflammatory markers, endothelial function and bone specific laboratory markers., At 0, 3 and 6 months|Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction., Entire intervention period, samples taken at 0,1,3, and 6 months|Change from baseline in quality of life score between groups (SF-36)., At 0 and 6 months|Effect on serum lipid levels and other biochemical markers, At 0, 3 and 6 months|Metabolomics analyses., At 0 and 6 months
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Aker | Collaborators: University of Oslo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-09
|
| Completion Date: |
2011-12
|
| Results First Posted: |
|
| Last Update Posted: |
2009-11-03
|
| Locations: |
Diabetes Laboratory, Oslo University Hospital Aker, Oslo, 0514, Norway
|
| URL: |
https://clinicaltrials.gov/show/NCT00992797
|
