NCT03871868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

March 11, 2019

Last Update Submit

March 12, 2019

Conditions

Keywords

25-hydroxyvitamin D

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels

    Vitamin D levels in blood test

    december 2018- march 2019

Study Arms (2)

study group

In Woman With Myoma Uteri

control group

In Woman Without Myoma Uteri

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details25-50 years old women with and without myoma uteri
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33403, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MyofibromaVitamin D DeficiencyPolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesOvarian CystsCystsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pınar kadiroğulları M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 12, 2019

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations