Vitamin D Treatment and Hypogonadism in Men - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypogonadism	Drug: Vitamin D supplementation in hypogonadal men Drug: Vitamin D supplementation in eugonadal men Drug: Placebo hypogonadal Drug: Placebo eugonadal	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

Total testosterone (TT) [ Time Frame: Change from baseline in TT at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Free testosterone (FT) [ Time Frame: Change from baseline in FT after 12 weeks ] [ Designated as safety issue: No ]
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) [ Time Frame: Change from baseline in HOMA-IR at 12 weeks ] [ Designated as safety issue: No ]
Lipid levels (total cholesterol) [ Time Frame: Change from baseline in total cholesterol at 12 weeks ] [ Designated as safety issue: No ]
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc [ Time Frame: Change from Baseline in AUCgluc at 12 weeks ] [ Designated as safety issue: No ]
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins [ Time Frame: Change from Baseline in AUCins at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vitamin D hypogonadal Vitamin D supplementation in hypogonadal men	Drug: Vitamin D supplementation in hypogonadal men Other Name: A11CC05 Colecalciferol
Experimental: Vitamin D eugonadal Vitamin D supplementation in eugonadal men	Drug: Vitamin D supplementation in eugonadal men Other Name: 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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748370

Contacts

Contact: Elisabeth Lerchbaum, MD

0043-316-385-81144

elisabeth.lerchbaum@medunigraz.at

Locations

Austria
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism	Recruiting
Graz, Austria, 8036
Contact: Elisabeth Lerchbaum, MD 0043-316-385-81144 elisabeth.lerchbaum@medunigraz.at

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Elisabeth Lerchbaum, MD

Medical University of Graz

More Information

No publications provided

Responsible Party:	Lerchbaum Elisabeth, MD, Clinical Professor, Medical University of Graz
ClinicalTrials.gov Identifier:	NCT01748370 History of Changes
Other Study ID Numbers:	VitDTesto1.0, 14846
Study First Received:	December 10, 2012
Last Updated:	December 13, 2012
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:

vitamin D
hypogonadism
testosterone
intervention

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013