Vitamin D Levels in Women With Polycystic Ovary Syndrome

• Sponsor: Ghamra Military Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05101811
• Collaborator: Al-Azhar University (Other)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Vitamin D Levels measurement using chemiluminescent assay; Device: Vitamin D level assessment	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel studyParallel study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Apr 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Levels of vitamin D in Polycystic ovary syndrome [1 year]

   vitamin D levels is assumed to be significantly decreased

Secondary Outcome Measures

1. Levels of vitamin D in fertile women [1 year]

   vitamin D level is expected to be normal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Misr Al Gadida Military hospital	Cairo		Egypt	11311

Sponsors and Collaborators

• Ghamra Military Hospital
• Al-Azhar University

Investigators

• Principal Investigator: Osama Mohamed, Ghamra Military Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osama Mansour Khalifa Mohamed, Principal investigator,obstetrics and gynecologydepartment, Ghamra Military Hospital
• ClinicalTrials.gov Identifier: NCT05101811
• Other Study ID Numbers: GhamraMH
• First Posted: Nov 1, 2021
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins

Study Results

No Results Posted as of Nov 1, 2021