NCT02513381

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

July 23, 2015

Last Update Submit

July 12, 2019

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

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

    Three months supplementation with Vitamin D3 3200IU or placebo

Secondary Outcomes (3)

  • 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

Study Arms (2)

Vitamin D3, 3200IU

ACTIVE COMPARATOR

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

Other: Vitamin D3, 3200IU

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin D3, 3200IUOTHER

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

Vitamin D3, 3200IU
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, HU3 2RW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30658483RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Thozhukat Sathyapalan, MD, FRCP

    University of Hull

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 31, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

GB(1)