Vitamin D Treatment and Hypogonadism in Men

NCT ID: NCT01748370

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2017-11-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin D hypogonadal

Vitamin D supplementation in hypogonadal men

Group Type: EXPERIMENTAL

Vitamin D supplementation in hypogonadal men

Intervention Type: DRUG

Vitamin D eugonadal

Vitamin D supplementation in eugonadal men

Group Type: EXPERIMENTAL

Vitamin D supplementation in eugonadal men

Intervention Type: DRUG

Placebo hypogonadal

Vitamin D supplementation in hypogonadal men

Group Type: PLACEBO_COMPARATOR

Placebo hypogonadal

Intervention Type: DRUG

Placebo eugonadal

Vitamin D supplementation in eugonadal men

Group Type: PLACEBO_COMPARATOR

Placebo eugonadal

Intervention Type: DRUG

Interventions

Vitamin D supplementation in hypogonadal men

Intervention Type: DRUG

Vitamin D supplementation in eugonadal men

Intervention Type: DRUG

Placebo hypogonadal

Intervention Type: DRUG

Placebo eugonadal

Intervention Type: DRUG

Other Intervention Names

A11CC05 Colecalciferol; A11CC05 Colecalciferol

Eligibility Criteria

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

• 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, 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:

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Lerchbaum Elisabeth, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth Lerchbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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

Graz, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 28938446 (View on PubMed)

Other Identifiers

14846

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VitDTesto1.0

Identifier Type: -

Identifier Source: org_study_id