Vitamin D Treatment and Hypogonadism in Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 26, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 26, 2014
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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014