Vitamin D Treatment and Hypogonadism in Men

This study is currently recruiting participants.
Verified October 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Lerchbaum Elisabeth, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01748370
First received: December 10, 2012
Last updated: October 28, 2013
Last verified: October 2013
  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:


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: October 28, 2013
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 April 17, 2014