Clinical trial · Observational
Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women
NCT05151393CI-TRIAL-00055448unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measuring vitamin D3 level | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Cases with uterine leiomyoma
- interventionNames
- Diagnostic Test: Measuring vitamin D3 level
- label
- Controls
- description
- Cases free of uterine leiomyoma
- interventionNames
- Diagnostic Test: Measuring vitamin D3 level
Primary outcomes (1)
- measure
- Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
- timeFrame
- 6 months
- description
- Low levels serum vitamin D as a risk factor for development of uterine leiomyoma.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDCorachan 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. PMID 31739978
- BACKGROUNDBouillon 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. PMID 30449548
- BACKGROUNDCiavattini 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. PMID 24803127
- BACKGROUNDCiebiera 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. PMID 32752274
- BACKGROUNDDrayer 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. PMID 26275638
- BACKGROUNDMas 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. PMID 28919823
- BACKGROUNDMettler 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.