NCT01721915

Vitamin D Treatment, Pharmacogenetics and Glucose Metabolism

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria. PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility. New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD) supplementation significantly improved glucose metabolism and fertility. However, the efficacy of vitD administration shows individual variability indicating endogenous influences on pharmacological effects. A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC) associated with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already been known to be associated with insulin resistance. Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD related genetic determinants adjusted for environmental factors. Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To generate the hypothesis that changes in metabolic and endocrine parameters following vitD treatment are associated with vitD related gene variants. Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, \[25(OH)D\]) levels \<30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. In addition, 150 non-PCOS women with 25(OH)D \<30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. The response to vitD supplementation in both groups will be analysed according to genotype profiles. Significance: VitD might be a new therapeutic option without major side effects for PCOS patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window for therapy modulation in PCOS and other metabolic diseases.

Conditions

• Polycystic Ovary Syndrome
• Healthy
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin D supplementation	The treatment group will receive an oral dose of 20,000 IU vitD weekly (equivalent to 2857 IU/day) as oily drops (Oleovit D3-drops; producer: Fresenius Kabi Austria GmbH, Linz)
DRUG	Placebo

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-10-12
• Completion: 2017-10-12
• First posted: 2012-11-06
• Last updated: 2018-03-20

Locations

1 site across 1 country: Austria