Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
297
20 000 Iu x2/week \+ calcium 500 mg/cholecalciferol 400 IU x2/d
Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w
Medical Dpt. B, University Hospital of Northern Norway
Tromsø, Norway
changes in bone mineral density in columna and total hip.
Time frame: One year
Muscle strength (hand grip strength and knee extension)
Time frame: One year
balance (tandem test)
Time frame: One year
body composition (Dexa)
Time frame: One year
inflammation markers
Time frame: One year
calcium and vitamin D metabolism
Time frame: One year
blood lipids
Time frame: One year
renal function
Time frame: One year
telomere length
Time frame: one year
perception of own health
Time frame: one year
Urinary tract symptoms
Time frame: one year
effects of polymorphisms in VDR on the other endpoints
Time frame: one year
side effects
Time frame: one year
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