NCT05101811

Brief Summary

Polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age. Its worldwide prevalence has been estimated between5-10%. Vitamin D, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient exposure to ultraviolet sunlight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2020

Shorter than P25 for phase_4

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

May 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 8, 2021

Last Update Submit

October 21, 2021

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Levels of vitamin D in Polycystic ovary syndrome

    vitamin D levels is assumed to be significantly decreased

    1 year

Secondary Outcomes (1)

  • Levels of vitamin D in fertile women

    1 year

Study Arms (2)

Control women without polycystic ovary syndrome

EXPERIMENTAL

Normal fertile women without polycystic ovary syndrome

Drug: Vitamin D Levels measurement using chemiluminescent assayDevice: Vitamin D level assessment

Case women with polycystic ovary syndrome

EXPERIMENTAL

Women with polycystic ovary syndrome

Drug: Vitamin D Levels measurement using chemiluminescent assayDevice: Vitamin D level assessment

Interventions

Vitamin D Levels measurement using chemiluminescent assayDRUG

Measurement of serum vitamin D levels

Case women with polycystic ovary syndromeControl women without polycystic ovary syndrome
Vitamin D level assessmentDEVICE

Using lIAISON DEVICE

Case women with polycystic ovary syndromeControl women without polycystic ovary syndrome

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hyperandrogenism
  • Polycystic ovary syndrome

You may not qualify if:

  • Thyroid disease
  • Parathyroid disease
  • Diabetes Mellitus
  • Cushing syndrome
  • Congenital adrenal hyperplasia
  • Hyperprolactinemia
  • Renal, liver or chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr Al Gadida Military hospital

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Osama Mohamed

    Ghamra Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator,obstetrics and gynecologydepartment

Study Record Dates

First Submitted

October 8, 2021

First Posted

November 1, 2021

Study Start

May 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Summary and results

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
1 year
Access Criteria
Al Azhar International Medical Journal
More information

Locations

EG(1)