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Vitamin D Treatment and Hypogonadism in Men

NCT01748370 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-20

No results posted yet for this study

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

DRUG

Vitamin D supplementation in hypogonadal men

DRUG

Vitamin D supplementation in eugonadal men

DRUG

Placebo hypogonadal

DRUG

Placebo eugonadal

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Elisabeth Lerchbaum, MD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748370 on ClinicalTrials.gov