Vitamin D and pharmakogenetics in glucose metabolism

Conditions: Polycystic Ovary Syndrome
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-000994-30-AT

Lead Sponsor: Medizinische Universität Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

PCOS women:
1) Premenopausal women =18 years
2) Polycystic ovary syndrome: 2 out of the following criterias are required:
a) Oligo- or anovulation
b) Biochemical and/or clinical hyperandrogenism
c) Polycystic ovaries
3) 25(OH)D <30 ng/ml

Healthy women:
1) Premenopausal women =18 years
2) Exclusion of Polycystic ovary syndrome
3) 25(OH)D <30 ng/ml

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PCOS women:
Hypercalcemia
Withdrawn informed consent
Hormonal contraception in the last 3 months before entering the study
Insulin sensitizing agents in the last 6 months before entering the study
Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
the study
Vitamin D supplementation in the last 3 months before entering the study
Hyperandrogenism caused by other diseases than polycystic ovary syndrome (Cushing disease, adrenogenital
syndrome)

Healthy women:
diagnosed PCOS or any of the following criteria:
Oligo- or anovulation, Biochemical and/or clinical hyperandrogenism, Polycystic ovaries

Hypercalcemia
Withdrawn informed consent
Hormonal contraception in the last 3 months before entering the study
Insulin sensitizing agents in the last 6 months before entering the study
Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
the study
Vitamin D supplementation in the last 3 months before entering the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of vitamin D supplementation when compared to placebo on AUCgluc in women with polycystic ovary syndrome.;Secondary Objective: To investigate the effect of vitamin D supplementation when compared to placebo on insulin resistance, insulin sensitivity, hyperandrogenemia and fertility in women with polycystic ovary syndrome. To investigate pharmacogenetic effects of vitamin D-related genetic variants. In addition, gene expression analyses of relevant candidate genes in association with pathways of vitamin D, androgens and metabolism will be performed at each visit in order to analyze functional changes during vitamin D treatment;Primary end point(s): 25-OH-vitamin D, 1,25-OH-vitamin D, PTH<br>oral glucose tolerance test (glucose, insulin, C-peptide), AUCgluc, AUCins<br>HOMA-index, QUICKI, MATSUDA, Proinsulin<br>HbA1c, serum lipids<br>;Timepoint(s) of evaluation of this end point: 12 weeks, 24 weeks

Secondary Outcome Measures