The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
1000 mg calcium per os every day for one year
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Helsinki, Finland
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Time frame: 12 months (including 9 time points)
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Time frame: 12 months (including 9 timepoints)
Hypercalciuria (dU-Ca >10 mmol/24h)
Time frame: 12 months (including 9 timepoints)
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Time frame: 12 months (including 9 timepoints)
Serum PTH
Time frame: 12 months (including 9 timepoints)
Serum PINP
Time frame: 12 months (including 5 timepoints)
Serum CTX
Time frame: 12 months (including 5 timepoints)
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