Vitamin D Deficit in Women With Uterine Fibroids

Completed

• Conditions: Leiomyoma; Fibroid Uterus; Vitamin D Deficiency
• Interventions: Diagnostic Test: Level of Vitamin D

• Registration Number: NCT04030182
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

Detailed Description

A cross-sectional prevalence study will be carried out, taking patients with a diagnosis of uterine fibroid in two hospitals; blood level of vitamin D will be taken to determine the proportion of patients with deficit and insufficiency; In addition, the number, size and type (according to the PALM-COEN classification) of the uterine fibroids in each patient will be analyzed.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Study Start: 2019-12-01
• Primary Completion: 2021-10-09
• Study Completion: 2021-10-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

Inclusion Criteria

• Female
• Diagnosis of uterine fibroid

Exclusion Criteria

• Female with diagnosis of uterine fibroid under treatment with exogenous vitamine D

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Level of vitamin D	Level of Vitamin D	Level in blood sample of vitamin D for each patient

Primary Outcome Measures

Name	Time	Method
appointment for intervention	15 minutes	All patients diagnosed with uterine fibroids who come for consultation, will be explained the protocol and if they agree to be part of it, an informed consent will be given and a 3 ml sample of venous blood will be taken.; The sample will be analize in a COBAS 6000 ANALYZER SERIES model c501 (by ROCHE) and the reference levels will be: 1-25 ng/mL - DEFICIT 25 - 30 ng/mL - INSUFFICIENCY \> 30 ng/mL - Normal; For this study, the qualitative variables will be expressed as frequencies and percentages (%); the quantitative variables will be expressed in means ± standard deviation. The prevalence of vitamin D deficiency at baseline will be calculated using the formula (total cases observed with vitamin D deficiency / total of patients included) X 100.

Trial Locations

Locations (2)

Hospital General Regional No. 45; 🇲🇽 Guadalajara, Jalisco, Mexico

Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia; 🇲🇽 Guadalajara, Jalisco, Mexico