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Completed

NCT Number: NCT02513381

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

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".

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, HU3 2RW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3, 3200IU

Other

Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.

Placebo

Other

Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.

Primary outcomes

  1. 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

Secondary outcomes

  1. Hormonal parameters including testosterone, SHBG and FAI.

    Time frame: Three months supplementation with Vitamin D3 3200IU or placebo

  2. Inflammatory marker hs-CRP

    Time frame: Three months supplementation with Vitamin D3 3200IU or placebo

  3. Endothelial function by EndoPAT

    Time frame: Three months supplementation with Vitamin D3 3200IU or placebo

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 31, 2015
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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