NCT01748370

Vitamin D Treatment and Hypogonadism in Men

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Vitamin D supplementation in hypogonadal men
DRUG	Vitamin D supplementation in eugonadal men
DRUG	Placebo hypogonadal
DRUG	Placebo eugonadal

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-11-12
• Completion: 2017-11-12
• First posted: 2012-12-12
• Last updated: 2018-03-20

Locations

1 site across 1 country: Austria