Hypogonadism
Conditions
Keywords
vitamin D, hypogonadism, testosterone, intervention
Brief summary
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.
Interventions
DRUGVitamin D supplementation in hypogonadal men
DRUGVitamin D supplementation in eugonadal men
DRUGPlacebo hypogonadal
DRUGPlacebo eugonadal
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total testosterone (TT) | Change from baseline in TT at 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Free testosterone (FT) | Change from baseline in FT after 12 weeks |
| Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) | Change from baseline in HOMA-IR at 12 weeks |
| Lipid levels (total cholesterol) | Change from baseline in total cholesterol at 12 weeks |
| Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc | Change from Baseline in AUCgluc at 12 weeks |
| Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins | Change from Baseline in AUCins at 12 weeks |
Countries
Austria
Outcome results
None listed