A randomized, double-blind, placebo controlled trial to evaluate the effects of vitamin D supplementation on androgen levels in hypogonadal men - Vitamin D&TT

Medizinische Universität Graz, Innere Medizin0 个研究点开始时间: 2013年2月4日最近更新: 2013年11月4日

适应症

试验速览

暂无简介。

•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

•-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)

发起方

Medizinische Universität Graz, Innere Medizin