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

NCT ID: NCT02513381

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-11-30

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D3, 3200IU

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

Group Type: ACTIVE_COMPARATOR

Vitamin D3, 3200IU

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Vitamin D3, 3200IU

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thozhukat Sathyapalan, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Hull

Locations

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 30658483 (View on PubMed)

Other Identifiers

14/YH/1125

Identifier Type: -

Identifier Source: org_study_id