Vitamin D Treatment and Hypogonadism in Men

March 17, 2018 updated by: Lerchbaum Elisabeth, MD, Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D hypogonadal
Vitamin D supplementation in hypogonadal men
Drug: Vitamin D supplementation in hypogonadal men
Other Names:
  • A11CC05 Colecalciferol
Experimental: Vitamin D eugonadal
Vitamin D supplementation in eugonadal men
Drug: Vitamin D supplementation in eugonadal men
Other Names:
  • A11CC05 Colecalciferol
Placebo Comparator: Placebo hypogonadal
Vitamin D supplementation in hypogonadal men
Drug: Placebo hypogonadal
Placebo Comparator: Placebo eugonadal
Vitamin D supplementation in eugonadal men
Drug: Placebo eugonadal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total testosterone (TT)
Time Frame: Change from baseline in TT at 12 weeks
Change from baseline in TT at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Free testosterone (FT)
Time Frame: Change from baseline in FT after 12 weeks
Change from baseline in FT after 12 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time Frame: Change from baseline in HOMA-IR at 12 weeks
Change from baseline in HOMA-IR at 12 weeks
Lipid levels (total cholesterol)
Time Frame: Change from baseline in total cholesterol at 12 weeks
Change from baseline in total cholesterol at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Time Frame: Change from Baseline in AUCgluc at 12 weeks
Change from Baseline in AUCgluc at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins
Time Frame: Change from Baseline in AUCins at 12 weeks
Change from Baseline in AUCins at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Elisabeth Lerchbaum, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

November 12, 2017

Study Completion (Actual)

November 12, 2017

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitDTesto1.0
  • 14846 (Other Grant/Funding Number: ÖNB Jubiläumsfond)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypogonadism

Clinical Trials on Vitamin D supplementation in hypogonadal men

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe