The Effect of Alfacalcidiol and Metformin on Phenotype Manifestations in Women with Polycystic Ovary Syndrome – a Preliminary Study

Abstract

Aim of this study was to evaluate the effect of vitamin D supplementation in obese, insulin resistant and vitamin D deficient PCOS women on biochemical and clinical hyperandrogenism and menstrual irregularity in comparison to effect of metformin or combined metformin plus vitamin D therapy. Thirty nine PCOS women were randomized into three groups and treated with alfacalcidiol (Group 1), combined alfacalcidiol and metformin therapy (Group 2) and metformin (Group 3) for 6 months. Serum TST, fTST, DHEAS, LH and LH/FSH were measured before and after six months of treatment. Menstrual cycle regularity, hirsutism, acne and pregnancy rate were assessed at the same time. There was a significant decrease in TST levels in the Group 2 and slight but not significant decrease in the Group 3. No significant changes in other parameters (fTST, DHEAS, LH, LH/FSH) have been found after 6 months therapy in all three groups. An improvement of menstrual cycle was detected in 78 % of patients in Group 1 (p<0.04), 80 % in the Group 2 (p<0.03) and in 90 % in the Group 3 (p<0.002), respectively. There was no significant improvement of acne and hirsutism in all three groups (all p not significant). Pregnancy rate was higher in the Group 3 as compared with Groups 1 and 2 (67 % vs. 0 % and 25 %, respectively), however without statistical significance. Vitamin D administration has no significant effect on androgen levels and clinical features of hyperandrogenism in obese vitamin D deficient PCOS women. However, it can potentiate effect of metformin on testosterone levels and LH/FSH ratio but not on clinical hyperandrogenism and pregnancy rate.

The effect of Vitamin D supplementation on hormonal and glycaemic profile of patients with PCOS: A meta-analysis of randomised trials

“…Nine studies were included in the present meta‐analysis which investigated the impact of vitamin D supplementation in 647 patients . The actual number of patients that were randomised in the various treatment groups is available in Table .…”

“…Only two studies investigated the impact of vitamin D on acne and hirsutism with conflicting evidence . Evidence regarding its action on menstrual cycle regularity remain also inconclusive …”

“…Firstly, the analysis should be specifically based on the severity of vitamin deficiency as previously stated in the present article. Furthermore, the additive effect of vitamin D supplementation on the hormonal and metabolic profile of patients treated with metformin deserves further investigation as current data are based only in two studies . Moreover, the investigation of the phenotypic alterations of PCOS such as acne and hirsutism with a thorough evaluation based on the Ferriman‐Gallwey classification is required as current data in the field remain very limited .…”

Effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome

“…In addition, vitamin D and calcium co-supplementation in PCOS women could result in a better outcome in a variety of PCOS symptoms, such as menstrual regularity, and ovulation [ 23 ]. However, vitamin D supplementation for 6 months among obese vitamin D-deficient PCOS women had no significant effect on androgen levels and clinical features of hyperandrogenism [ 24 ]. In addition, two meta-analysis studies conducted by He et al [ 8 ] and Xue et al [ 9 ] demonstrated no evidence that vitamin D intake reduced or mitigated metabolic and hormonal profiles in PCOS women.…”

Vitamin D and Gynecologic Outcomes: Insights from the EAGeR Trial

“…We became interested in understanding vitamin D's influence on androgens because polycystic ovary syndrome (PCOS) is simultaneously the most common endocrinopathy in women worldwide (18)-specifically causing hyperandrogenism specifically-and the most common cause of ovulatory dysfunction (19). One small study of normal-BMI PCOS patients and healthy, non-obese women demonstrated a positive relationship between vitamin D and total testosterone (TT) (20) while another similar study found no relationship (21). Results among postmenopausal women show a negative relationship between vitamin D and TT (22,23).…”