Vitamin D Deficit in Women With Uterine Fibroids

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Completed
CT.gov ID
NCT04030182
Collaborator
(none)
127
2
22.3
63.5
2.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Level of Vitamin D

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 Design

Study Type:
Observational
Actual Enrollment :
127 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Vitamin D Deficit in Women With Uterine Fibroids
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Oct 9, 2021
Actual Study Completion Date :
Oct 9, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Female

  • Diagnosis of uterine fibroid

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia Guadalajara Jalisco Mexico 44600
2 Hospital General Regional No. 45 Guadalajara Jalisco Mexico 44600

Sponsors and Collaborators

  • Instituto Mexicano del Seguro Social

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Luis Esteban González Varela, Gynecology Specialist, Adscript to the Gynecology Service in Regional General Hospital #45, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT04030182
Other Study ID Numbers:
  • VIDANFI
First Posted:
Jul 23, 2019
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2021