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Vitamin D Treatment and Hypogonadism in Men

Primary Purpose

Hypogonadism

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Vitamin D supplementation in hypogonadal men

Vitamin D supplementation in eugonadal men

Placebo hypogonadal

Placebo eugonadal

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring vitamin D, hypogonadism, testosterone, intervention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D hypogonadal

Vitamin D eugonadal

Placebo hypogonadal

Placebo eugonadal

Arm Description

Vitamin D supplementation in hypogonadal men

Vitamin D supplementation in eugonadal men

Vitamin D supplementation in hypogonadal men

Vitamin D supplementation in eugonadal men

Outcomes

Primary Outcome Measures

Total testosterone (TT)

Secondary Outcome Measures

Free testosterone (FT)

Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

Lipid levels (total cholesterol)

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins

Full Information

NCT ID

NCT01748370

First Posted

December 10, 2012

Last Updated

March 17, 2018

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT01748370

Brief Title

Vitamin D Treatment and Hypogonadism in Men

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

December 1, 2012 (Actual)

Primary Completion Date

November 12, 2017 (Actual)

Study Completion Date

November 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Graz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

vitamin D, hypogonadism, testosterone, intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D hypogonadal

Arm Type

Experimental

Arm Description

Vitamin D supplementation in hypogonadal men

Arm Title

Vitamin D eugonadal

Arm Type

Experimental

Arm Description

Vitamin D supplementation in eugonadal men

Arm Title

Placebo hypogonadal

Arm Type

Placebo Comparator

Arm Description

Vitamin D supplementation in hypogonadal men

Arm Title

Placebo eugonadal

Arm Type

Placebo Comparator

Arm Description

Vitamin D supplementation in eugonadal men

Intervention Type

Drug

Intervention Name(s)

Vitamin D supplementation in hypogonadal men

Other Intervention Name(s)

A11CC05 Colecalciferol

Intervention Type

Drug

Intervention Name(s)

Vitamin D supplementation in eugonadal men

Other Intervention Name(s)

A11CC05 Colecalciferol

Intervention Type

Drug

Intervention Name(s)

Placebo hypogonadal

Intervention Type

Drug

Intervention Name(s)

Placebo eugonadal

Primary Outcome Measure Information:

Title

Total testosterone (TT)

Time Frame

Change from baseline in TT at 12 weeks

Secondary Outcome Measure Information:

Title

Free testosterone (FT)

Time Frame

Change from baseline in FT after 12 weeks

Title

Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

Time Frame

Change from baseline in HOMA-IR at 12 weeks

Title

Lipid levels (total cholesterol)

Time Frame

Change from baseline in total cholesterol at 12 weeks

Title

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc

Time Frame

Change from Baseline in AUCgluc at 12 weeks

Title

Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins

Time Frame

Change from Baseline in AUCins at 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Lerchbaum, MD

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

28938446

Citation

Lerchbaum E, Pilz S, Trummer C, Schwetz V, Pachernegg O, Heijboer AC, Obermayer-Pietsch B. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4292-4302. doi: 10.1210/jc.2017-01428.

Results Reference

derived

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Vitamin D Treatment and Hypogonadism in Men

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