Effect of Vitamin D on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Colecalciferol (Vitamin D) on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Double Blind Randomised Placebo-controlled Study

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Vitamin D3, 3200IU
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian women, aged 18-45 years, with confirmed diagnosis of PCOS based on all three diagnostic criteria of the Rotterdam consensus [21]. Irregular periods with raised FAI Vitamin D < 50 nmol/L. Exclusion Criteria: Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests if clinically indicated. Any concurrent illness including type 2 diabetes, subjects who are on any medication (including medications that interfere with calceotrophic hormones) for the preceding 6 months. Women planning to conceive. Women who are using any oral or implantable contraceptives or any other treatments likely to affect ovarian function, insulin sensitivity or lipids for at least 3 months before entering the study. Stable dose of metformin for 3 months is allowed. Subjects will be advised to use barrier contraception during the study period. eGFR<60. Hypersensitivity to vitamin D or any of the excipients in the product. Peanut or soya allergy. Nephrolithiasis. Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3, 3200IU<br>Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. | Other: Vitamin D3, 3200IU<br>* Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.<br>|
| Placebo Comparator: Placebo<br>Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months. | Other: Placebo<br>* Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile |  | Three months supplementation with Vitamin D3 3200IU or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal parameters including testosterone, SHBG and FAI. |  | Three months supplementation with Vitamin D3 3200IU or placebo | 
| Inflammatory marker hs-CRP |  | Three months supplementation with Vitamin D3 3200IU or placebo | 
| Endothelial function by EndoPAT |  | Three months supplementation with Vitamin D3 3200IU or placebo |