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Vitamin D Levels in Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D Levels measurement using chemiluminescent assay
Vitamin D level assessment
Sponsored by
Ghamra Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Misr Al Gadida Military hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control women without polycystic ovary syndrome

Case women with polycystic ovary syndrome

Arm Description

Normal fertile women without polycystic ovary syndrome

Women with polycystic ovary syndrome

Outcomes

Primary Outcome Measures

Levels of vitamin D in Polycystic ovary syndrome
vitamin D levels is assumed to be significantly decreased

Secondary Outcome Measures

Levels of vitamin D in fertile women
vitamin D level is expected to be normal

Full Information

First Posted
October 8, 2021
Last Updated
October 21, 2021
Sponsor
Ghamra Military Hospital
Collaborators
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05101811
Brief Title
Vitamin D Levels in Women With Polycystic Ovary Syndrome
Official Title
Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ghamra Military Hospital
Collaborators
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.
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.

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
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control women without polycystic ovary syndrome
Arm Type
Experimental
Arm Description
Normal fertile women without polycystic ovary syndrome
Arm Title
Case women with polycystic ovary syndrome
Arm Type
Experimental
Arm Description
Women with polycystic ovary syndrome
Intervention Type
Drug
Intervention Name(s)
Vitamin D Levels measurement using chemiluminescent assay
Intervention Description
Measurement of serum vitamin D levels
Intervention Type
Device
Intervention Name(s)
Vitamin D level assessment
Intervention Description
Using lIAISON DEVICE
Primary Outcome Measure Information:
Title
Levels of vitamin D in Polycystic ovary syndrome
Description
vitamin D levels is assumed to be significantly decreased
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Levels of vitamin D in fertile women
Description
vitamin D level is expected to be normal
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Mohamed
Organizational Affiliation
Ghamra Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misr Al Gadida Military hospital
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Summary and results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Al Azhar International Medical Journal
IPD Sharing URL
https://aimj.journals.ekb.eg/

Learn more about this trial

Vitamin D Levels in Women With Polycystic Ovary Syndrome

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