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Vitamin D Levels And Myoma Uteri

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03871868
Collaborator
(none)
300
Enrollment
1
Location
3
Actual Duration (Months)
101.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Vitamin D Levels İn Women With and Without Myoma Uteri
    Actual Study Start Date :
    Dec 1, 2018
    Actual Primary Completion Date :
    Mar 1, 2019
    Actual Study Completion Date :
    Mar 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    study group

    In Woman With Myoma Uteri
    control group

    In Woman Without Myoma Uteri

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin D levels [december 2018- march 2019]

      Vitamin D levels in blood test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    Female

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kanuni Sultan Süleyman Training and Research Hospital Istanbul Turkey 33403

    Sponsors and Collaborators

    • Kanuni Sultan Suleyman Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pınar Kadirogulları, pınar kadiroğulları M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03871868
    Other Study ID Numbers:
    • 2018/11/43
    First Posted:
    Mar 12, 2019
    Last Update Posted:
    Mar 14, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pınar Kadirogulları, pınar kadiroğulları M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
    25-hydroxyvitamin D
    Additional relevant MeSH terms:
    Myoma
    Leiomyoma
    Myofibroma
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Mar 14, 2019