Polycystic Ovary Syndrome
Conditions
Interventions
Trade Name: Oleovit D3-Tropfen
Pharmaceutical Form: Oral drops
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
Concentration unit: IU/m
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: PCOS women: Hypercalcemia Withdrawn informed consent Hormonal contraception in the last 3 months before entering the study Insulin sensitizing agents in the last 6 months before entering the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criteria: Oligo- or anovulation, Biochemical and/or clinical hyperandrogenism, Polycystic ovaries Hypercalcemia Withdrawn informed consent Hormonal contraception in the last 3 months before entering the study Insulin sensitizing agents in the last 6 months before entering the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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 oral glucose tolerance test (glucose, insulin, C-peptide), AUCgluc, AUCins HOMA-index, QUICKI, MATSUDA, Proinsulin HbA1c, serum lipids ;Timepoint(s) of evaluation of this end point: 12 weeks, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): menstrual frequency endocrine parameters (testosterone, free testosterone, SHBG, prolactin, androstendione, DHEAS, 17-OHprogesterone) Lipometry questionnaires, hirsutism-score (Ferriman-Gallway-score) Transvaginal ultrasound Genotypes-pharmacogenetic effects Gene expression analyses (candidate genes: androgen receptor (AR), estrogen receptor (ER), aromatase (Cyp19), FOXL2 (Forkhead Box Protein L2), STAR (Steroidogenic acute regulatory protein), Cytochrom-P11, Cytochrom-P17, receptors of FSH and LH, SHBG, anti- und proinflammatory genes (Interleukines, Interferon, FOXP3 (forkhead box P3),…), genes related to glucose metabolism (IGF-1 (Insulin-like growth factor 1), IGF-1R (Insulin-like growth factor 1 Rezeptor), IGF-BP (Insulin-like growth factor binding proteins), INSL (Insulin-like peptides), insulin receptor (IR),…) and Vitamin D metabolism (Vitamin-D-Rezeptor (VDR), Cyp2R1, Cyp27A1, Cyp24A1, Cyp27B, as well as genes of TGF-beta superfamily (inhibin, activin und its receptors, follistatin, Transforming Growth Factors und its receptors, BMPs, AMH, Growth and Differentiation Factor 9 (GDF9)).;Timepoint(s) of evaluation of this end point: 12 weeks, 24 weeks | — |
Countries
Austria
Contacts
Public ContactInformation für Klinische Studien
Medizinische Universität Graz
Outcome results
None listed