Vitamin D Treatment and Hypogonadism in Men

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748370
• Other study ID #: VitDTesto1.0
• Secondary ID: 14846
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2012
• Last updated: March 17, 2018
• Start date: December 1, 2012
• Est. completion date: November 12, 2017

Study information

• Verified date: March 2018
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 12, 2017
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Vitamin D supplementation in hypogonadal men

• Vitamin D supplementation in eugonadal men

• Placebo hypogonadal

• Placebo eugonadal

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total testosterone (TT)		Change from baseline in TT at 12 weeks
Secondary	Free testosterone (FT)		Change from baseline in FT after 12 weeks
Secondary	Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)		Change from baseline in HOMA-IR at 12 weeks
Secondary	Lipid levels (total cholesterol)		Change from baseline in total cholesterol at 12 weeks
Secondary	Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc		Change from Baseline in AUCgluc at 12 weeks
Secondary	Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins		Change from Baseline in AUCins at 12 weeks