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NCT03871868 Clinical Trial

Vitamin D Levels And Myoma Uteri

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Levels İn Women With and Without Myoma Uteri

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03871868
Other study ID # 2018/11/43
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date March 1, 2019

Study information
Verified date March 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers
Gender Female
Age group 25 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin D levels Vitamin D levels in blood test december 2018- march 2019
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