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Trial record 64 of 566 for:    "Polycystic Ovary Syndrome"

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

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ClinicalTrials.gov Identifier: NCT02513381
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Thozhukat Sathyapalan, University of Hull

Brief Summary:
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".

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: Vitamin D3, 3200IU Other: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official 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
Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vitamin D3, 3200IU
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
Other: Vitamin D3, 3200IU
Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Caucasian women, aged 18-45 years, with confirmed diagnosis of PCOS based on all three diagnostic criteria of the Rotterdam consensus [21].
  2. Irregular periods with raised FAI
  3. Vitamin D < 50 nmol/L.

Exclusion Criteria:

  1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests if clinically indicated.
  2. 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.
  3. Women planning to conceive.
  4. 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.
  5. eGFR<60.
  6. Hypersensitivity to vitamin D or any of the excipients in the product.
  7. Peanut or soya allergy.
  8. Nephrolithiasis.
  9. Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513381


Locations
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United Kingdom
Michael White Centre for Diabetes and Endocrinology
Hull, East Yorkshire, United Kingdom, HU3 2RW
Sponsors and Collaborators
University of Hull
Hull and East Yorkshire Hospitals NHS Trust
Investigators
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Principal Investigator: Thozhukat Sathyapalan, MD, FRCP University of Hull

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Responsible Party: Thozhukat Sathyapalan, Dr, University of Hull
ClinicalTrials.gov Identifier: NCT02513381     History of Changes
Other Study ID Numbers: 14/YH/1125
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents