Vitamin D Treatment and Hypogonadism in Men

Phase 4

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Vitamin D supplementation in hypogonadal men; Drug: Vitamin D supplementation in eugonadal men; Drug: Placebo eugonadal; Drug: Placebo hypogonadal

• Registration Number: NCT01748370
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-01
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2017-11-12
• Study Completion: 2017-11-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-17
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D hypogonadal	Vitamin D supplementation in hypogonadal men	Vitamin D supplementation in hypogonadal men
Vitamin D eugonadal	Vitamin D supplementation in eugonadal men	Vitamin D supplementation in eugonadal men
Placebo eugonadal	Placebo eugonadal	Vitamin D supplementation in eugonadal men
Placebo hypogonadal	Placebo hypogonadal	Vitamin D supplementation in hypogonadal men

Primary Outcome Measures

Name	Time	Method
Total testosterone (TT)	Change from baseline in TT at 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism; 🇦🇹 Graz, Austria