This is a double blind randomised placebo-controlled study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo for three months. The main hypothesis of this study is "Vitamin D improves hormonal, metabolic and cardiovascular risk markers in women with PCOS".
Polycystic ovary syndrome (PCOS) is a very common condition in women which could present with irregular periods, excessive hair growth on body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease. One of the risk factors for having increased incidence of such problems in PCOS patients could be low vitamin D levels as many women with polycystic ovary syndrome (PCOS) are vitamin D deficient. Vitamin D supplementation may have a beneficial effect on insulin levels and fat around the abdomen. It has been seen in previous research studies that low level of vitamin D is related to a greater risk of diabetes and heart disease. Low vitamin D levels are also associated with fat in the liver. The amount of fat in the liver is a sign of early liver disease. So, in this study the investigators want to supplement women having PCOS and vitamin D deficiency with vitamin D (3,200 IU) and examine the effects on hormones related to PCOS and risk factors for diabetes and heart disease in them.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
40
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
Michael White Centre for Diabetes and Endocrinology
Hull, East Yorkshire, United Kingdom
Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
Hormonal parameters including testosterone, SHBG and FAI.
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
Inflammatory marker hs-CRP
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
Endothelial function by EndoPAT
Time frame: Three months supplementation with Vitamin D3 3200IU or placebo
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