Vitamin D Treatment and Hypogonadism in Men

NCT01748370 | Completed Phase 4 DMC

• 2 other identifiers: VitDTesto1.014846
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Keywords

vitamin D; hypogonadism; testosterone; intervention

Outcome Measures

Primary Outcomes (1)

• Total testosterone (TT)

  Change from baseline in TT at 12 weeks

Secondary Outcomes (5)

• Free testosterone (FT)

  Change from baseline in FT after 12 weeks

• Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

  Change from baseline in HOMA-IR at 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 AUCgluc

  Change from Baseline in AUCgluc at 12 weeks

• Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins

  Change from Baseline in AUCins at 12 weeks

Study Arms (4)

Vitamin D hypogonadal

EXPERIMENTAL

Vitamin D supplementation in hypogonadal men

Drug: Vitamin D supplementation in hypogonadal men

Vitamin D eugonadal

EXPERIMENTAL

Vitamin D supplementation in eugonadal men

Drug: Vitamin D supplementation in eugonadal men

Placebo hypogonadal

PLACEBO COMPARATOR

Vitamin D supplementation in hypogonadal men

Drug: Placebo hypogonadal

Placebo eugonadal

PLACEBO COMPARATOR

Vitamin D supplementation in eugonadal men

Drug: Placebo eugonadal

Interventions

Vitamin D supplementation in hypogonadal men DRUG

Also known as: A11CC05 Colecalciferol

Vitamin D hypogonadal

Vitamin D supplementation in eugonadal men DRUG

Also known as: A11CC05 Colecalciferol

Vitamin D eugonadal

Placebo hypogonadal DRUG

Placebo hypogonadal

Placebo eugonadal DRUG

Placebo eugonadal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TT levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
• (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

You may not qualify if:

• \- 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:
• TT levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism

Graz, 8036, Austria

Location

Related Publications (1)

• Lerchbaum E, Pilz S, Trummer C, Schwetz V, Pachernegg O, Heijboer AC, Obermayer-Pietsch B. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4292-4302. doi: 10.1210/jc.2017-01428.

  PMID: 28938446 DERIVED

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Elisabeth Lerchbaum, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: November 12, 2017
• Study Completion: November 12, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

AU (1)