Elisabeth Lerchbaum1, Stefan Pilz1, Christian Trummer1, Verena Schwetz1, Oliver Pachernegg2, Annemieke C Heijboer3,4, Barbara Obermayer-Pietsch1. 1. Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, 8036 Graz, Austria. 2. Department of Urology, Medical University of Graz, 8036 Graz, Austria. 3. Department of Clinical Chemistry, Endocrine Laboratory, VU University Medical Center, 1081 HV Amsterdam, The Netherlands. 4. Laboratory of Endocrinology, Academic Medical Center, 1105 AZ Amsterdam, The Netherlands.
Abstract
Context: Available evidence shows an association of vitamin D with androgen levels in men. However, results from preliminary randomized controlled trials (RCTs) are conflicting. Objective: To evaluate whether vitamin D supplementation increases total testosterone (TT) levels in healthy men. Design: The Graz Vitamin D&TT-RCT is a single-center, double-blind, randomized, placebo-controlled trial conducted between December 2012 and January 2017. Setting: Endocrine outpatient clinic at the Medical University of Graz, Austria. Participants: Ninety-eight healthy men with TT levels ≥10.4 nmol/L and 25-hydroxyvitamin D [25(OH)D] levels <75 nmol/L completed the study. Intervention: Subjects were randomly assigned to receive 20,000 IU/wk of vitamin D3 (n = 50) or placebo (n = 50) for 12 weeks. Main Outcome Measures: Primary outcome was TT measured using mass spectrometry. Secondary outcomes were free testosterone, sex hormone-binding globulin, estradiol, follicle-stimulating hormone, and luteinizing hormone levels; free androgen index; metabolic characteristics; and body composition. Results: In healthy men [mean values ±standard deviation: age, 39 years (±13 years); 25(OH)D level, 53.3 nmol/L (±18.3 nmol/L); TT, 19.1 nmol/L (±5.6 nmol/l)], no significant treatment effect on TT was found; however, there were significant effects on quantitative insulin sensitivity check index (QUICKI) and a trend toward decreased Matsuda index. In the treatment group, median (interquartile range) changes for TT, QUICKI, and Matsuda index were 0.5 nmol/L (-0.63 to 0.63 nmol/L; P = 0.497), -0.02 (-0.04 to 0.01; P = 0.034), and -0.9 (-3.2 to 0.8; P = 0.051), respectively. Conclusion:Vitamin D treatment had no effect on TT levels in middle-aged healthy men with normal baseline TT, but it significantly decreased QUICKI. Additional studies investigating vitamin D effects on TT and insulin sensitivity in healthy men are required.
RCT Entities:
Context: Available evidence shows an association of vitamin D with androgen levels in men. However, results from preliminary randomized controlled trials (RCTs) are conflicting. Objective: To evaluate whether vitamin D supplementation increases total testosterone (TT) levels in healthy men. Design: The Graz Vitamin D&TT-RCT is a single-center, double-blind, randomized, placebo-controlled trial conducted between December 2012 and January 2017. Setting: Endocrine outpatient clinic at the Medical University of Graz, Austria. Participants: Ninety-eight healthy men with TT levels ≥10.4 nmol/L and 25-hydroxyvitamin D [25(OH)D] levels <75 nmol/L completed the study. Intervention: Subjects were randomly assigned to receive 20,000 IU/wk of vitamin D3 (n = 50) or placebo (n = 50) for 12 weeks. Main Outcome Measures: Primary outcome was TT measured using mass spectrometry. Secondary outcomes were free testosterone, sex hormone-binding globulin, estradiol, follicle-stimulating hormone, and luteinizing hormone levels; free androgen index; metabolic characteristics; and body composition. Results: In healthy men [mean values ± standard deviation: age, 39 years (±13 years); 25(OH)D level, 53.3 nmol/L (±18.3 nmol/L); TT, 19.1 nmol/L (±5.6 nmol/l)], no significant treatment effect on TT was found; however, there were significant effects on quantitative insulin sensitivity check index (QUICKI) and a trend toward decreased Matsuda index. In the treatment group, median (interquartile range) changes for TT, QUICKI, and Matsuda index were 0.5 nmol/L (-0.63 to 0.63 nmol/L; P = 0.497), -0.02 (-0.04 to 0.01; P = 0.034), and -0.9 (-3.2 to 0.8; P = 0.051), respectively. Conclusion:Vitamin D treatment had no effect on TT levels in middle-aged healthy men with normal baseline TT, but it significantly decreased QUICKI. Additional studies investigating vitamin D effects on TT and insulin sensitivity in healthy men are required.
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