Vitamin D Levels in Women With Polycystic Ovary Syndrome

October 21, 2021 updated by: Osama Mansour Khalifa Mohamed, Ghamra Military Hospital

Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this work is assessment of the level of vitamin D in female have polycystic ovary syndrome & healthy female.and also make diagnostic criteria for patient who is in need for supplementations with vitamin D.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Misr Al Gadida Military hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Hyperandrogenism
  • Polycystic ovary syndrome

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Control women without polycystic ovary syndrome
Normal fertile women without polycystic ovary syndrome
Drug: Vitamin D Levels measurement using chemiluminescent assay
Measurement of serum vitamin D levels
Device: Vitamin D level assessment
Using lIAISON DEVICE
EXPERIMENTAL: Case women with polycystic ovary syndrome
Women with polycystic ovary syndrome
Drug: Vitamin D Levels measurement using chemiluminescent assay
Measurement of serum vitamin D levels
Device: Vitamin D level assessment
Using lIAISON DEVICE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of vitamin D in Polycystic ovary syndrome
Time Frame: 1 year
vitamin D levels is assumed to be significantly decreased
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of vitamin D in fertile women
Time Frame: 1 year
vitamin D level is expected to be normal
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ghamra Military Hospital

Collaborators

Al-Azhar University

Investigators

  • Principal Investigator: Osama Mohamed, Ghamra Military Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (ACTUAL)

November 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GhamraMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Summary and results

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

Al Azhar International Medical Journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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