Vitamin D Deficit in Women With Uterine Fibroids
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
-
Female
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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
- Bläuer M, Rovio PH, Ylikomi T, Heinonen PK. Vitamin D inhibits myometrial and leiomyoma cell proliferation in vitro. Fertil Steril. 2009 May;91(5):1919-25. doi: 10.1016/j.fertnstert.2008.02.136. Epub 2008 Apr 18.
- Lukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211.
- Pavone D, Clemenza S, Sorbi F, Fambrini M, Petraglia F. Epidemiology and Risk Factors of Uterine Fibroids. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:3-11. doi: 10.1016/j.bpobgyn.2017.09.004. Epub 2017 Oct 1. Review.
- VIDANFI