- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871868
Vitamin D Levels And Myoma Uteri
March 12, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Vitamin D Levels İn Women With and Without Myoma Uteri
Women with at least one uterine leiomyoma and polycystic ovary syndrome over 10 mm and women with normal ultrasonographic findings were included in the study.
Blood samples were taken for biochemical analysis such as vitamin D, calcium, magnesium, phosphorus, thyroid stimulating hormone (TSH), hemoglobin (hb), hematocrit (htc), platelet (plt), and albumin.
The study groups were compared in terms of these biochemical markers and family history of patients, daily sunshine hours, clothing preferences and education level.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
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
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-
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Istanbul, Turkey, 33403
- Kanuni Sultan Suleyman Training and Research Hospital
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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
25 years to 50 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The reproductive age women (25-50 years) with at least one 10 mm or larger diameter leiomyoma detected by transvaginal ultrasound were the study group.
Description
Inclusion Criteria: The reproductive age women (25-50 years) with at least one 10 mm or larger diameter leiomyoma detected by transvaginal ultrasound were the study group.
Exclusion Criteria:
- Patients with a history of myomectomy,
- chronic systemic disease
- malignancy
- history of adenomyosis
- women in menopause
- pregnant women
- vitamin D supplementation
- lactation
- abortion and pregnancy loss in the last 6 months
- oral contraceptive / hormonal agents in the last 3 months
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
Cohorts and Interventions
Group / Cohort |
---|
study group
In Woman With Myoma Uteri
|
control group
In Woman Without Myoma Uteri
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D levels
Time Frame: december 2018- march 2019
|
Vitamin D levels in blood test
|
december 2018- march 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 1, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 12, 2019
Study Record Updates
Last Update Posted (Actual)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/11/43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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