Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
NCT ID: NCT05151393
Last Updated: 2021-12-09
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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UNKNOWN
80 participants
OBSERVATIONAL
2021-12-01
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Cases with uterine leiomyoma
Measuring vitamin D3 level
Measuring vitamin D3 in both groups
Controls
Cases free of uterine leiomyoma
Measuring vitamin D3 level
Measuring vitamin D3 in both groups
Interventions
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Measuring vitamin D3 level
Measuring vitamin D3 in both groups
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed Samy
Obs/Gyn resident
Principal Investigators
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Rania Gamal, MD
Role: STUDY_DIRECTOR
Ain Shams University
Mortada Elsayed, MD
Role: STUDY_DIRECTOR
Ain Shams University
Aliaa Maaty, MD
Role: STUDY_DIRECTOR
Ain Shams University
Magdy Hassan, MD
Role: STUDY_CHAIR
AinShansU
Central Contacts
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References
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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.
Matsui MS. Vitamin D Update. Curr Dermatol Rep. 2020;9(4):323-330. doi: 10.1007/s13671-020-00315-0. Epub 2020 Oct 14.
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.
Singh V, Barik A, Imam N. Vitamin D3 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.
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):3832. doi: 10.3390/ijms20153832.
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.
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.
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.
Corachan A, Ferrero H, Escrig J, Monleon J, Faus A, Cervello 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.
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.
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.
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):5528. doi: 10.3390/ijms21155528.
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.
Mas A, Tarazona M, Dasi Carrasco J, Estaca G, Cristobal I, Monleon 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.
Other Identifiers
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VitaminD and Uterine leiomyoma
Identifier Type: -
Identifier Source: org_study_id