The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D \< 100 nmol/L. If serum 25(OH)D \> 100 placebo will be given. The cholecalciferol will be given in orange juice.
Orange juice at randomization day and at week 5.
Diabetes Laboratory, Oslo University Hospital Aker
Oslo, Norway
RECRUITINGInsulin sensitivity measured with euglycemic, hyperinsulinemic clamp
Time frame: Before and after the 6 months intervention period
Insulin secretion measured with IVGTT
Time frame: At 0 and 6 months
Physical activity/muscle strength
Time frame: At 0 and 6 months
HbA1c and fasting glucose
Time frame: At 0, 3 and 6 months
Arterial stiffness
Time frame: At 0 and 6 months
Differences in inflammatory markers, endothelial function and bone specific laboratory markers.
Time frame: At 0, 3 and 6 months
Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.
Time frame: Entire intervention period, samples taken at 0,1,3, and 6 months
Change from baseline in quality of life score between groups (SF-36).
Time frame: At 0 and 6 months
Effect on serum lipid levels and other biochemical markers
Time frame: At 0, 3 and 6 months
Metabolomics analyses.
Time frame: At 0 and 6 months
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