Vitamin D and testosterone in me

Conditions: Male hypogonadism (total testosterone <3ng/ml)
MedDRA version: 14.1Level: HLTClassification code 10000193Term: Male sex hormone abnormalitiesSystem Organ Class: 100000004872
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2011-003575-11-AT

Lead Sponsor: Medizinische Universität Graz, Innere Medizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Hypogonadal men:

-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

COntrol group
-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)