Vitamin D Deficit in Women With Uterine Fibroids

November 4, 2021 updated by: Luis Esteban González Varela, Instituto Mexicano del Seguro Social
Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia
      • Guadalajara, Jalisco, Mexico, 44600
        • Hospital General Regional No. 45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • Female
  • Diagnosis of uterine fibroid

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Level of vitamin D
Level in blood sample of vitamin D for each patient
Diagnostic test: Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appointment for intervention
Time Frame: 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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Luis Esteban Gonzalez Varela, PhD, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

October 9, 2021

Study Completion (Actual)

October 9, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIDANFI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

because is an internal study in the hospital, and the committe doesn´s accept share any information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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