drugset / Trial / NCT01748370

Vitamin D Treatment and Hypogonadism in Men

NCT01748370

Phase 4 Completed 200 enrolled Medical University of Graz
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2012-12-01
Primary completion
2017-11-12
Completion
2017-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 20000 iu

Indications