The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients
Condition: Polycystic Ovary Syndrome; Vitamin D Deficiency/Insufficiency
MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate the safety and metabolic-hormonal efficiency of
      supplementation vitamin D deficient/insufficient PCOS women with (calcium +vitamin D +
      metformin) for 8 weeks compared to (placebo+ metformin).
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among females of
      reproductive age. The main manifestations of this syndrome are ovulatory dysfunction,
      hyperandrogenism, and polycystic ovarian morphology. Noticeably, PCOS is associated with
      several metabolic disturbances such as insulin resistance, compensatory hyperinsulinemia,
      dyslipidemia and central obesity, which increase the risk for long-term complications like
      type 2 diabetes mellitus, metabolic syndrome, and cardiovascular diseases. Moreover, previous
      data demonstrated that, compared to normo-ovulatory women, PCOS patients might exhibit a
      dysregulation in the IGF system represented as an elevation in the serum levels of free
      Insulin-like growth factor-1 (IGF-1) and a reduction in the serum levels of Insulin-like
      growth factor binding protein-1 (IGFBP-1). However, the exact aetiology of PCOS remains
      unclear and current treatments are only moderately effective at controlling PCOS symptoms and
      preventing its complications. Growing evidence suggests a role of vitamin D in female
      reproductive diseases as the expression of Vitamin D Receptors (VDR) was identified in many
      organs throughout the female reproductive tract. On the top of that, vitamin D regulates over
      300 genes, including genes that are important for glucose and lipid metabolism. Moreover,
      vitamin D deficiency is a common condition among women with PCOS, and several studies
      indicated an association between low levels of serum 25-hydroxyvitamin D (25-OH-Vitamin D)
      and manifestations of PCOS including insulin resistance, hyperandrogenism, and infertility.
      Further, a recent in-vitro study showed that vitamin D regulated steroidogenesis and IGFBP-1
      production in cultured human ovarian cells, and many reports have suggested an interrelation
      between IGF-1 and vitamin D.
    

Intervention name(s): Vitamin D3; Calcium Carbonate; Metformin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug; Drug
Intervention description(s): Vitamin D3 (Cholecalciferol) (6000 IU/daily). PO for 8 weeks.; Calcium carbonate (1000 mg/daily). PO for 8 weeks.; Metformin (1500 mg/daily; the metformin dose was increased stepwise, starting with 500 mg once daily for the 1st week, 500 mg twice daily in the 2nd week, followed by 500 mg 3 times daily from the 3rd week onward). PO for 8 weeks.; PO for 8 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Metformin; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Calcium; Vitamin D; Metformin