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临床试验/NCT04030182
NCT04030182已完成不适用

Vitamin D Deficit in Women With Uterine Fibroids

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
2
主要终点
appointment for intervention

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of uterine fibroid

排除标准

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

结局指标

主要结局

appointment for intervention

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Luis Esteban González Varela

Gynecology Specialist, Adscript to the Gynecology Service in Regional General Hospital #45

Instituto Mexicano del Seguro Social

研究点 (2)

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