Clinical trial NCT04030182: Vitamin D Deficit in Women With Uterine Fibroids
Official title: Vitamin D Deficit in Women With Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiomyoma
Vitamin D Deficiency
Fibroid Uterus
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2019-07-23
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All female patients diagnosed with uterine myomatosis who come for consultation, if they agree to be part of protocol, an informed consent will be given and a 3 ml sample of venous blood will be taken.

The present study will be performed in two Hospitals:

"Centro Médico Nacional de Occidente" (CMNO) "Hospital General Regional No. 45" (HGR 45) Both hospital established in the city of Guadalajara, Jalisco, Mexico.

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.

Eligibility criteria: Inclusion Criteria:

* Female
* Diagnosis of uterine fibroid

Exclusion Criteria:

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

Primary outcomes:
measure: appointment for intervention
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital General Regional No. 45
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Luis Esteban Gonzalez Varela, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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