Vitamin D Deficit in Women With Uterine Fibroids

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Deficit in Women With Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030182
• Other study ID #: VIDANFI
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: October 9, 2021

Study information

• Verified date: November 2021
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 9, 2021
• Est. primary completion date: October 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female

• Diagnosis of uterine fibroid

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Level of Vitamin D
3 ml of venous blood will be taken to determine the level of vitamin D

Locations

Country	Name	City	State
Mexico	Centro Médico Nacional de Occidente, Hospital de Gineco-Obstetricia	Guadalajara	Jalisco
Mexico	Hospital General Regional No. 45	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (17)

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

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. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Available from http:// — View Citation

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. — View Citation

Holick MF. Vitamin D: A millenium perspective. J Cell Biochem. 2003 Feb 1;88(2):296-307. Review. — View Citation

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. — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

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. 2 — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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