Vitamin D Treatment and Hypogonadism in Men

Hypogonadal men:

Inclusion criteria

• TT levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
• 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
• Male, age of ≥ 18 and <70 years
• Written informed consent before entered into study

Exclusion criteria

• - Hypercalcemia defined as a serum calcium > 2,7 mmol/L
• Oral or transdermal testosterone supplementation in the last 2 months before entering the study
• IM testosterone supplementation 6 months before entering the study
• Regular intake of vitamin D supplements before study entry
• Men with chronic diseases (such as diabetes mellitus, thyroid disease, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
• Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,…) in the last 3 months before study entry
• PSA >4 ng/ml (or >3 ng/ml in men at high risk for prostate cancer) (see state of the art)
• Palpable prostate nodule or induration
• Hematocrit >50%
• Untreated severe obstructive sleep apnea
• Severe lower urinary tract symptoms
• Uncontrolled or poorly controlled heart failure
• A history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. Klinefelter Syndrome)

Eugonadal men:

Inclusion criteria

• TT levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
• 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
• Male, age of ≥ 18 and <70 years
• Written informed consent before entered into study

Exclusion criteria

• Hypercalcemia defined as a serum calcium > 2,7 mmol/L
• Oral or transdermal testosterone supplementation in the last 2 months before entering the study
• IM testosterone supplementation 6 months before entering the study
• Regular intake of vitamin D supplements before study entry
• Men with chronic diseases (such as diabetes mellitus, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
• Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,…) in the last 3 months before study entry
• PSA >4 ng/ml (or >3 ng/ml in men at high risk for prostate cancer) (see state of the art)
• Palpable prostate nodule or induration
• Hematocrit >50%
• Untreated severe obstructive sleep apnea
• Severe lower urinary tract symptoms
• Uncontrolled or poorly controlled heart failure
• A history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. Klinefelter)