Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma

Vitamin D Deficiency Clinical Trial

Official title:

Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05151393
• Other study ID #: VitaminD and Uterine leiomyoma
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: November 2021
• Source: Ain Shams University
• Contact: Mohamed Samy, Bachelor
• Phone: 00201141423818
• Email: dr.mohamed.tolis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 15, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age ranging from 20 to 45 years.

2. Postmenstrual patients to exclude current pregnancy.

3. Parity up to para 3 by either normal vaginal delivery or cesarean section.

4. Body mass index (BMI) ranging from 18 to 30 kg/m2.

5. One or more uterine fibroid with a diameter ranging from 3-10 cm.

6. Fibroids either subserous, intramural or submucous uterine fibroids

Exclusion Criteria:

1. Women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin D deficiency after this age.

2. Patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin D levels may be lower than baseline for nonpregnant ones.

3. Grand multipara >3 times frequently associated with vitamin D deficiency.

4. Cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency.

5. Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.

6. Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.

7. Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).

8. Small fibroid less than 3cm diameter may not be enough size to cause changes in lab results or large ones more than 10 cm diameter.

9. Previous myomectomy or hysterectomy.

10. Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.

11. Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.

12. Current smokers or history of smoking as it decreases the production of the active form of vitamin D.

13. Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.

14. Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.

15. Current treatment with heparin as it interferes with vitamin D activation.

16. Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.

Related Conditions & MeSH terms

• Leiomyoma
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Measuring vitamin D3 level
Measuring vitamin D3 in both groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (14)

Bouillon R, Carmeliet G. Vitamin D insufficiency: Definition, diagnosis and management. Best Pract Res Clin Endocrinol Metab. 2018 Oct;32(5):669-684. doi: 10.1016/j.beem.2018.09.014. Epub 2018 Oct 3. Review. — View Citation

Ciavattini A, Clemente N, Delli Carpini G, Di Giuseppe J, Giannubilo SR, Tranquilli AL. Number and size of uterine fibroids and obstetric outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(4):484-8. doi: 10.3109/14767058.2014.921675. Epub 2014 Jun 5. — View Citation

Ciebiera M, Ali M, Zgliczynska M, Skrzypczak M, Al-Hendy A. Vitamins and Uterine Fibroids: Current Data on Pathophysiology and Possible Clinical Relevance. Int J Mol Sci. 2020 Aug 1;21(15). pii: E5528. doi: 10.3390/ijms21155528. Review. — View Citation

Corachán A, Ferrero H, Escrig J, Monleon J, Faus A, Cervelló I, Pellicer A. Long-term vitamin D treatment decreases human uterine leiomyoma size in a xenograft animal model. Fertil Steril. 2020 Jan;113(1):205-216.e4. doi: 10.1016/j.fertnstert.2019.09.018. Epub 2019 Nov 15. — View Citation

Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet. 2015 Nov;131(2):117-22. doi: 10.1016/j.ijgo.2015.04.051. Epub 2015 Aug 5. Review. — View Citation

Mas A, Tarazona M, Dasí Carrasco J, Estaca G, Cristóbal I, Monleón J. Updated approaches for management of uterine fibroids. Int J Womens Health. 2017 Sep 5;9:607-617. doi: 10.2147/IJWH.S138982. eCollection 2017. Review. — View Citation

Matsui MS. Vitamin D Update. Curr Dermatol Rep. 2020 Oct 14:1-8. doi: 10.1007/s13671-020-00315-0. [Epub ahead of print] Review. — View Citation

Mettler L, Schollmeyer T, Tinelli A, Malvasi A, Alkatout I. Complications of Uterine Fibroids and Their Management, Surgical Management of Fibroids, Laparoscopy and Hysteroscopy versus Hysterectomy, Haemorrhage, Adhesions, and Complications. Obstet Gynecol Int. 2012;2012:791248. doi: 10.1155/2012/791248. Epub 2012 Apr 9. — View Citation

Sheng B, Song Y, Liu Y, Jiang C, Zhu X. Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial. BMJ Open. 2020 Nov 6;10(11):e038709. doi: 10.1136/bmjopen-2020-038709. — View Citation

Singh V, Barik A, Imam N. Vitamin D(3) Level in Women with Uterine Fibroid: An Observational Study in Eastern Indian Population. J Obstet Gynaecol India. 2019 Apr;69(2):161-165. doi: 10.1007/s13224-018-1195-4. Epub 2018 Dec 6. — View Citation

Sirajudeen S, Shah I, Al Menhali A. A Narrative Role of Vitamin D and Its Receptor: With Current Evidence on the Gastric Tissues. Int J Mol Sci. 2019 Aug 5;20(15). pii: E3832. doi: 10.3390/ijms20153832. Review. — View Citation

Srivastava P, Gupta HP, Singhi S, Khanduri S, Rathore B. Evaluation of 25-hydroxy vitamin D3 levels in patients with a fibroid uterus. J Obstet Gynaecol. 2020 Jul;40(5):710-714. doi: 10.1080/01443615.2019.1654986. Epub 2019 Oct 22. — View Citation

Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512. doi: 10.1111/1471-0528.14640. Epub 2017 May 13. — View Citation

Szkodziak P, Pyra K, Szkodziak F, Krzyzanowski J, Czuczwar P, Wozniak S, Jargiello T, Paszkowski T. The Lublin Protocol of the Uterine Arteries Embolization in the Treatment of Symptomatic Uterine Fibroids. J Vis Exp. 2020 Sep 15;(163). doi: 10.3791/61530. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.	Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.	6 months
Secondary	Correlation of low serum vitamin D with size, site and number of fibroids	Correlation of low serum vitamin D with size, site and number of fibroids	6 months
Secondary	Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma	Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma	6 months
Secondary	Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).	Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).	6 months