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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Vitamin D3, 3200IU

Placebo

About this trial

This is an interventional health services research trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Michael White Centre for Diabetes and Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3, 3200IU

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiovascular risk assessment by hs-CRP, HOMA (fasting glucose & insulin) and fasting lipid profile

Secondary Outcome Measures

Hormonal parameters including testosterone, SHBG and FAI.

Inflammatory marker hs-CRP

Endothelial function by EndoPAT

Full Information

NCT ID

NCT02513381

First Posted

July 23, 2015

Last Updated

July 12, 2019

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

1. Study Identification

Unique Protocol Identification Number

NCT02513381

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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".

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3, 3200IU

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Vitamin D3, 3200IU

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Hormonal parameters including testosterone, SHBG and FAI.

Time Frame

Three months supplementation with Vitamin D3 3200IU or placebo

Title

Inflammatory marker hs-CRP

Time Frame

Three months supplementation with Vitamin D3 3200IU or placebo

Title

Endothelial function by EndoPAT

Time Frame

Three months supplementation with Vitamin D3 3200IU or placebo

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thozhukat Sathyapalan, MD, FRCP

Organizational Affiliation

University of Hull

Official's Role

Principal Investigator

Facility Information:

Facility Name

Michael White Centre for Diabetes and Endocrinology

City

Hull

State/Province

East Yorkshire

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30658483

Citation

Javed Z, Papageorgiou M, Deshmukh H, Kilpatrick ES, Mann V, Corless L, Abouda G, Rigby AS, Atkin SL, Sathyapalan T. A Randomized, Controlled Trial of Vitamin D Supplementation on Cardiovascular Risk Factors, Hormones, and Liver Markers in Women with Polycystic Ovary Syndrome. Nutrients. 2019 Jan 17;11(1):188. doi: 10.3390/nu11010188.

Results Reference

result

Links:

URL

https://www.mdpi.com/2072-6643/11/1/188/htm

Description

Publication Link

Learn more about this trial

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

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