Low total testosterone (TT) is present in about 30% of men aged \>60 years and in up to 7% of younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as well as with increased mortality. There is evidence showing a relationship of TT with vitamin D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a 12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT \<3.0 ng/ml and 25-hydroxyvitamin D (25(OH)D) \<30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml and 25(OH)D \<30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the effects of vitamin D on androgens will be evaluated in eugonadal men.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Graz, Austria
Total testosterone (TT)
Time frame: Change from baseline in TT at 12 weeks
Free testosterone (FT)
Time frame: Change from baseline in FT after 12 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time frame: Change from baseline in HOMA-IR at 12 weeks
Lipid levels (total cholesterol)
Time frame: Change from baseline in total cholesterol at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Time frame: Change from Baseline in AUCgluc at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins
Time frame: Change from Baseline in AUCins at 12 weeks
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