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Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level of vitamin D | Level in blood sample of vitamin D for each patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Level of Vitamin D | Diagnostic Test | 3 ml of venous blood will be taken to determine the level of vitamin D |
|
| Measure | Description | Time Frame |
|---|---|---|
| appointment for intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women with uterus and diagnosis of Uterine Leyomioma
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.
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| Name | Affiliation | Role |
|---|---|---|
| Luis Esteban Gonzalez Varela, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia | Guadalajara | Jalisco | 44600 | Mexico | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18423458 | Background | 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. | |
| 29054502 | Background | 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. |
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because is an internal study in the hospital, and the committe doesn´s accept share any information
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 16, 2025 | |
| Reset | Nov 25, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 16, 2025 | Nov 25, 2025 |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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3 ml of venous blood sample to determine levels of vitamin D
| Hospital General Regional No. 45 |
| Guadalajara |
| Jalisco |
| 44600 |
| Mexico |
| 30969201 | Background | 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. |
| 21646368 | Result | 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. |
| 29344677 | Result | 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. |
| 21939083 | Result | 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. |
| 27793369 | Result | 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. |
| 25879830 | Result | 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. |
| 26613601 | Result | 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. |
| 28030942 | Result | 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. |
| 12520530 | Result | Holick MF. Vitamin D: A millenium perspective. J Cell Biochem. 2003 Feb 1;88(2):296-307. doi: 10.1002/jcb.10338. |
| Result | 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 |
| 30789683 | Result | 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/ |
| 21345435 | Result | 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. |
| 26725703 | Result | 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. |
| 30316905 | Result | 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. |
| 23891629 | Result | 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. |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |