A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total testosterone (TT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- 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)
研究组 & 干预措施
Vitamin D hypogonadal
Vitamin D supplementation in hypogonadal men
干预措施: Vitamin D supplementation in hypogonadal men (Drug)
Vitamin D eugonadal
Vitamin D supplementation in eugonadal men
干预措施: Vitamin D supplementation in eugonadal men (Drug)
Placebo hypogonadal
Vitamin D supplementation in hypogonadal men
干预措施: Placebo hypogonadal (Drug)
Placebo eugonadal
Vitamin D supplementation in eugonadal men
干预措施: Placebo eugonadal (Drug)
结局指标
主要结局
Total testosterone (TT)
时间窗: Change from baseline in TT at 12 weeks
次要结局
- Free testosterone (FT)(Change from baseline in FT after 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 AUCins(Change from Baseline in AUCins at 12 weeks)
- Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc(Change from Baseline in AUCgluc at 12 weeks)
- Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)(Change from baseline in HOMA-IR at 12 weeks)
研究者
Lerchbaum Elisabeth, MD
Clinical Professor
Medical University of Graz