Polycystic Ovary SyndromePhase 4NCT05101811
Vitamin D Levels in Women With Polycystic Ovary Syndrome
A Phase 4 study testing Vitamin D Levels measurement using chemiluminescent assay and Vitamin D level assessment in people with Polycystic Ovary Syndrome, run by Ghamra Military Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Vitamin D Levels measurement using chemiluminescent assay and Vitamin D level assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hyperandrogenism
- Polycystic ovary syndrome
Who cannot join
- Thyroid disease
- Parathyroid disease
- Diabetes Mellitus
- Cushing syndrome
- Congenital adrenal hyperplasia
- Hyperprolactinemia
- Renal, liver or chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Vitamin D Levels measurement using chemiluminescent assay, Vitamin D level assessment
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D Levels measurement using chemiluminescent assayDrug
Measurement of serum vitamin D levels
Vitamin D level assessmentDevice
Using lIAISON DEVICE
| Study group | Role | What they receive |
|---|---|---|
| Control women without polycystic ovary syndrome | Experimental | Normal fertile women without polycystic ovary syndrome Receives: Drug: Vitamin D Levels measurement using chemiluminescent assay; Device: Vitamin D level assessment |
| Case women with polycystic ovary syndrome | Experimental | Women with polycystic ovary syndrome Receives: Drug: Vitamin D Levels measurement using chemiluminescent assay; Device: Vitamin D level assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of vitamin D in Polycystic ovary syndrome
vitamin D levels is assumed to be significantly decreased
Measured: 1 year
Secondary outcomes (1)
Levels of vitamin D in fertile women
vitamin D level is expected to be normal
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 May 2020
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghamra Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Osama Mansour Khalifa Mohamed, Ghamra Military Hospital
- Investigators
- Osama Mohamed, Principal investigator, Ghamra Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101811
- Sponsor's protocol ID
- GhamraMH
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Summary and results
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05101811
- Acronym / sponsor ID
- GhamraMH
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ghamra Military HospitalUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel study
| Arm | Type | Receives |
|---|---|---|
| Control women without polycystic ovary syndrome | Experimental | Drug: Vitamin D Levels measurement using chemiluminescent assay, Device: Vitamin D level assessmentNormal fertile women without polycystic ovary syndrome |
| Case women with polycystic ovary syndrome | Experimental | Drug: Vitamin D Levels measurement using chemiluminescent assay, Device: Vitamin D level assessmentWomen with polycystic ovary syndrome |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hyperandrogenism
- Polycystic ovary syndrome
Key exclusion criteria (7 listed)
- Thyroid disease
- Parathyroid disease
- Diabetes Mellitus
- Cushing syndrome
- Congenital adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D Levels measurement using chemiluminescent assayMeasurement of serum vitamin D levels | Drug | Case women with polycystic ovary syndrome, Control women without polycystic ovary syndrome |
| Vitamin D level assessmentUsing lIAISON DEVICE | Device | Case women with polycystic ovary syndrome, Control women without polycystic ovary syndrome |
Primary outcome
Levels of vitamin D in Polycystic ovary syndrome
Time frame: 1 year
vitamin D levels is assumed to be significantly decreased
1 secondary outcome
Levels of vitamin D in fertile women
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: Yes. Summary and results
Related trials for Polycystic Ovary Syndrome
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Mohamed principal investigator
Ghamra Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D Levels measurement using chemiluminescent assay and Vitamin D level assessment in people with Polycystic Ovary Syndrome, run by Ghamra Military Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of vitamin D in Polycystic ovary syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.