Vitamin D Treatment and Hypogonadism in Men

• Status: Completed
• Trial end date: 2017-11-12
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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

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)