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Vitamin D Deficit in Women With Uterine Fibroids

Vitamin D Deficit in Women With Uterine Fibroids

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04030182
Enrollment
127
Registered
2019-07-23
Start date
2019-12-01
Completion date
2021-10-09
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid Uterus, Leiomyoma, Vitamin D Deficiency

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.

Interventions

DIAGNOSTIC_TESTLevel of Vitamin D

3 ml of venous blood will be taken to determine the level of vitamin D

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Female * Diagnosis of uterine fibroid

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
appointment for intervention15 minutesAll 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026