Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2019-12-01
2021-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Level of vitamin D
Level in blood sample of vitamin D for each patient
Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D
Interventions
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Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of uterine fibroid
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Luis Esteban González Varela
Gynecology Specialist, Adscript to the Gynecology Service in Regional General Hospital #45
Principal Investigators
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Luis Esteban Gonzalez Varela, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia
Guadalajara, Jalisco, Mexico
Hospital General Regional No. 45
Guadalajara, Jalisco, Mexico
Countries
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References
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Blauer 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.
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.
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.
Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
Cashman KD, Sheehy T, O'Neill CM. Is vitamin D deficiency a public health concern for low middle income countries? A systematic literature review. Eur J Nutr. 2019 Feb;58(1):433-453. doi: 10.1007/s00394-018-1607-3. Epub 2018 Jan 17.
Atkinson SA. [The new dietary reference intakes from the Institute of Medicine for calcium and vitamin D]. Perspect Infirm. 2011 Sep-Oct;8(5):5. No abstract available. French.
Halder S, Al-Hendy A. Hypovitaminosis D and high serum transforming growth factor beta-3: important biomarkers for uterine fibroids risk. Fertil Steril. 2016 Dec;106(7):1648-1649. doi: 10.1016/j.fertnstert.2016.09.048. Epub 2016 Oct 25. No abstract available.
Jukic AM, Steiner AZ, Baird DD. Lower plasma 25-hydroxyvitamin D is associated with irregular menstrual cycles in a cross-sectional study. Reprod Biol Endocrinol. 2015 Mar 11;13:20. doi: 10.1186/s12958-015-0012-5.
Protic O, Toti P, Islam MS, Occhini R, Giannubilo SR, Catherino WH, Cinti S, Petraglia F, Ciavattini A, Castellucci M, Hinz B, Ciarmela P. Possible involvement of inflammatory/reparative processes in the development of uterine fibroids. Cell Tissue Res. 2016 May;364(2):415-27. doi: 10.1007/s00441-015-2324-3. Epub 2015 Nov 27.
Skowronska P, Pastuszek E, Kuczynski W, Jaszczol M, Kuc P, Jakiel G, Woclawek-Potocka I, Lukaszuk K. The role of vitamin D in reproductive dysfunction in women - a systematic review. Ann Agric Environ Med. 2016 Dec 23;23(4):671-676. doi: 10.5604/12321966.1226865.
Holick MF. Vitamin D: A millenium perspective. J Cell Biochem. 2003 Feb 1;88(2):296-307. doi: 10.1002/jcb.10338.
Ali, M. et al. Vitamin D synergizes the antiproliferative, apoptotic, antifibrotic and anti-inflammatory effects of ulipristal acetate against human uterine fibroids Fertility and Sterility, Volume 108, Issue 3, e66
Hartmann KE, Fonnesbeck C, Surawicz T, Krishnaswami S, Andrews JC, Wilson JE, Velez-Edwards D, Kugley S, Sathe NA. Management of Uterine Fibroids [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Dec. Report No.: 17(18)-EHC028-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK537742/
Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
Styer AK, Rueda BR. The Epidemiology and Genetics of Uterine Leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018. Epub 2015 Dec 2.
Dubuisson J. The current place of mini-invasive surgery in uterine leiomyoma management. J Gynecol Obstet Hum Reprod. 2019 Feb;48(2):77-81. doi: 10.1016/j.jogoh.2018.10.004. Epub 2018 Oct 12.
Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol. 2013 Oct;209(4):319.e1-319.e20. doi: 10.1016/j.ajog.2013.07.017. Epub 2013 Jul 24.
Other Identifiers
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VIDANFI
Identifier Type: -
Identifier Source: org_study_id