A Phase 4 interventional study of Vitamin D supplementation and Placebo in Polycystic Ovary Syndrome, Healthy and Vitamin D Deficiency, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 330 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
PCOS women:
Control women:
Exclusion Criteria:
PCOS women:
Control women:
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: Vitamin D supplementation
the placebo group will receive oily drops without vitD
Drug: Placebo
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)
Also known as: A11CC05 Colecalciferol
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Time frame: Change from Baseline in AUC gluc at 24 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time frame: Change from Baseline in insulin resistance at 24 weeks
Lipid levels (total cholesterol)
Time frame: Change from Baseline in total cholesterol at 24 weeks
HbA1c
Time frame: Change from Baseline in HbA1c at 24 weeks
Testosterone
Time frame: Change from Baseline in testosterone at 24 weeks
Menstrual frequency
Time frame: Change from Baseline in menstrual frequency at 24 weeks
Insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Time frame: Change from baseline in QUICKI at 24 weeks
Free testosterone (FT)
Time frame: Change from Baseline in FT at 4 weeks
Triglycerides
Time frame: Change from Baseline in triglycerides at 24 weeks
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Graz