Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT05151393
Status:
UNKNOWN
Last Update Posted:
2021-12-09
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-11-27', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Correlation of low serum vitamin D with size, site and number of fibroids', 'timeFrame': '6 months', 'description': 'Correlation of low serum vitamin D with size, site and number of fibroids'}, {'measure': 'Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma', 'timeFrame': '6 months', 'description': 'Correlation of low serum vitamin D with severity of symptoms related to uterine leiomyoma'}, {'measure': 'Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).', 'timeFrame': '6 months', 'description': 'Role of vitamin D deficiency in development of uterine leiomyoma in high risk groups (black race, obese patients).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '31739978', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30449548', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24803127', 'type': 'BACKGROUND', '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.'}, {'pmid': '32752274', 'type': 'BACKGROUND', '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):5528. doi: 10.3390/ijms21155528.'}, {'pmid': '26275638', 'type': 'BACKGROUND', '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.'}, {'pmid': '28919823', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22619681', 'type': 'BACKGROUND', '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.'}, {'pmid': '33078087', 'type': 'BACKGROUND', 'citation': 'Matsui MS. Vitamin D Update. Curr Dermatol Rep. 2020;9(4):323-330. doi: 10.1007/s13671-020-00315-0. Epub 2020 Oct 14.'}, {'pmid': '33158822', 'type': 'BACKGROUND', '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.'}, {'pmid': '30956471', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31387330', 'type': 'BACKGROUND', '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):3832. doi: 10.3390/ijms20153832.'}, {'pmid': '31635506', 'type': 'BACKGROUND', '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.'}, {'pmid': '28296146', 'type': 'BACKGROUND', '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.'}, {'pmid': '33016950', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population: (N=80) Women with symptomatic uterine fibroids attending the gynecology outpatient clinic and age matched controls free from uterine leiomyoma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ranging from 20 to 45 years.\n2. Postmenstrual patients to exclude current pregnancy.\n3. Parity up to para 3 by either normal vaginal delivery or cesarean section.\n4. Body mass index (BMI) ranging from 18 to 30 kg/m2.\n5. One or more uterine fibroid with a diameter ranging from 3-10 cm.\n6. Fibroids either subserous, intramural or submucous uterine fibroids\n\nExclusion Criteria:\n\n1. 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.\n2. 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.\n3. Grand multipara \\>3 times frequently associated with vitamin D deficiency.\n4. 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.\n5. Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.\n6. Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.\n7. Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).\n8. 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.\n9. Previous myomectomy or hysterectomy.\n10. Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.\n11. Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.\n12. Current smokers or history of smoking as it decreases the production of the active form of vitamin D.\n13. Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.\n14. Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.\n15. Current treatment with heparin as it interferes with vitamin D activation.\n16. Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.'}, 'identificationModule': {'nctId': 'NCT05151393', 'briefTitle': 'Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women', 'orgStudyIdInfo': {'id': 'VitaminD and Uterine leiomyoma'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Measuring vitamin D3 level', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measuring vitamin D3 in both groups', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Samy, Bachelor', 'role': 'CONTACT', 'email': 'dr.mohamed.tolis@gmail.com', 'phone': '00201141423818'}], 'overallOfficials': [{'name': 'Rania Gamal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mortada Elsayed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Aliaa Maaty, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Magdy Hassan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AinShansU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obs/Gyn resident', 'investigatorFullName': 'Mohamed Samy', 'investigatorAffiliation': 'Ain Shams University'}}}}