The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Vitamin D Deficiency
MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency; Syndrome
Intervention: Vitamin D3; Placebo
Intervention description: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.; Women in the placebo arm received once capsule of placebo once weekly for eight weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No

Summary:

      Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is
      characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction,
      hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating
      evidence suggests that the dysregulation of some angiogenic factors, such as transforming
      growth factor-β (TGF-β) and vascular endothelial growth factor (VEGF), may be implicated.
      TGF-βs and VEGF exert a diverse range of biological functions regulating cell proliferation,
      angiogenesis, fibroblast activation and tissue fibrosis. PCOS ovaries show all the hallmarks
      of TGF-β and VEGF upregulation, including increased collagen deposition in ovarian stroma and
      theca, supported by increased vascularity. Consistent with this, The investigators recently
      showed that TGF-β1 is increased in serum of PCOS women while its circulating receptor soluble
      endoglin (sENG) is decreased, resulting in greater TGF-β1 bioavailability. Furthermore, it
      has been shown that women with PCOS have increased VEGF levels in the serum and/or follicular
      fluid. PCOS patients also have decreased vitamin D levels, and vitamin D treatment has been
      previously shown to improve various clinical parameters in PCOS women, including glucose
      intolerance, hypertension and androgen levels. Interestingly, vitamin D has been shown to
      decrease TGF-β1 and VEGF levels in several diseases, including myelofibrosis and various
      human cancer cells. Therefore, the investigators hypothesize that vitamin D treatment of PCOS
      women will result in a decrease of serum TGF-β1 levels and/or VEGF levels concomitant with
      improvement in clinical disease parameters. In addition, the investigators hypothesize that
      improvement in clinical disease parameters will correlate with changes in serum VEGF levels
      and TGF-β1 bioavailability. Our aim in the present study is to investigate the effects of
      vitamin D treatment on serum VEGF and TGF-β1/sENG levels in PCOS women, and assess whether
      changes in these angiogenic factors following vitamin D treatment correlate with clinical
      disease in these women. For this end, PCOS patients who are vitamin D-deficient will be
      treated with vitamin D and their serum levels of VEGF, TGF-β1 and its sENG receptor will be
      measured before and after treatment. In addition, clinical disease parameters will be
      recorded before and 4 months after treatment, including serum glucose and insulin levels,
      serum androgen levels, and blood pressure.

      The proposed study aims to identify a putative link between vitamin D, VEGF, and TGF-β1 in
      the context of PCOS, and provide a novel molecular explanation for the beneficial clinical
      effects of vitamin D on PCOS patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with PCOS who have vitamin D deficiency (serum 25-hydroxyvitamin D<20 ng/mL)

        Exclusion Criteria:

          -  Pregnant, postpartum, breast feeding

          -  Taking Metformin, vitamin D, or any hormonal therapy