Vitamin D and Calcium As Novel Regulators of Reproductive Hormones and Sex Steroids in Copenhagen Bone Gonadal Study: A Randomized Clinical Trial

Program: Abstracts - Orals, Poster Previews, and Posters
Session: SUN 176-202-Male Reproductive Endocrinology and Male Reproductive Tract (posters)
Bench to Bedside
Sunday, April 3, 2016: 1:15 PM-3:15 PM
Exhibit/Poster Hall (BCEC)

Poster Board SUN 181
Martin Blomberg Jensen*1, Jacob Gerner Lawaetz2, Anna-Maria Andersson2, Anders Juul2 and Niels Jørgensen2
1Harvard University, Boston, MA, 2University of Copenhagen, Faculty of Health and Medical Sciences, Copenhagen, Denmark
Context:

Newer studies have indicated that vitamin D may have more widespread effects than the classical effects on bone and calcium-phosphate homeostasis. The presence of the vitamin D receptor in the testis and male reproductive tract indicates a role for vitamin D in male reproduction

Objective:

To investigate changes in the reproductive, skeletal and endocrine organs following 5 months supplementation with high dose vitamin D and calcium or placebo in infertile men. 

Design:

A single center, double blinded randomized clinical trial of 330 Danish infertile men with vitamin D insufficiency (serum 25-OHD < 50 nmol/l) conducted from 2011-2015. 

Setting:

Tertiary referral centre for andrology.

Participants:

All men were part of an infertile couple and were referred due to low semen quality. In total, 1421 infertile men were screened. 1090 men were excluded due to high vitamin D levels, azoospermia, serious associated comorbidities, medication or no desire to participate, yielding 330 men eligible for inclusion in the study. Of the 330 men who gave informed consent 309 showed up day 1 and started treatment with vitamin D + calcium or placebo.

Main Outcome Measures:

All 309 men underwent DXA scanning, delivered two semen samples and one blood sample prior to treatment start and again after 150 days intervention. The effect of one oral 300,000 IE cholecalciferol loading dose in addition to a daily 1400 IE cholecalciferol + 500 mg calcium dose for 5 months was compared with placebo on semen quality, clinical pregnancies, serum 25-hydroxyvitamin D, 1,25dihydroxyvitamin D, calcium ion, AMH, Inhibin B, LH, FSH and sex steroid levels.

Results:

More than 88% of the infertile men completed the study. Two semen analyses prior to the intervention and at follow up day 150 provide a reliable estimate of semen quality before and after the intervention. Serum analyses are being conducted currently using LCMS for vitamin D metabolites and validated ELISAs for sex steroids, AMH, Inhibin B, FSH and LH. The study will be un-blinded December 2015.  

Conclusions:

This is the first randomized clinical trial investigating the effect of vitamin D supplementation to infertile men. This study will show whether supplementation with cholecalciferol and calcium influences reproductive function and changes the endocrine crosslink between bone and gonads in infertile men.

Trial ID: NCT01304927

Nothing to Disclose: MB, JGL, AMA, AJ, NJ

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting/pr-resources-for-endo