Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT07012161
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-31', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.', 'timeFrame': '18 months', 'description': 'Fibroid size by cm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptomatic Uterine Fibroid']}, 'descriptionModule': {'briefSummary': '39 women with symptomatic uterine fibroid with serum vitamin D deficiency will receive vitamin D3 supplementation for 6 month.then symptoms and size of fibroid will be re evaluated..', 'detailedDescription': 'Effects of vitamin D supplimentation on symptomatic uterine fibroid will be checked'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n.Women aged between 18-50 not currently pregnant, lactating, or planning to conceive during the study period.\n\n* Women with a confirmed diagnosis of uterine fibroids (leiomyoma) through ultrasound.\n* Serum 25-hydroxyvitamin D \\[25(OH)D\\] levels below 20 ng/mL (indicating vitamin D deficiency).\n* Presence of symptoms associated with uterine fibroid, such as menorrhagia (heavy menstrual bleeding), or bulk-related symptoms (e.g., urinary frequency).\n* Participants should be generally healthy, with no history of other chronic illnesses that could affect the study's outcomes (e.g., autoimmune diseases, cancers, severe liver or kidney diseases).\n* Willingness to provide written informed consent for participation in the study.\n* No current use of hormonal therapy, other vitamin D supplements, or medications known to influence calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).\n* Participants must be willing and able to adhere to the study protocol, including attending follow-up visits and completing any required assessments or tests.\n\nExclusion Criteria:\n\n* Women younger than 18 or older than 50 years.\n* Serum 25-hydroxyvitamin D \\[25(OH)D\\] levels of 20 ng/mL or higher.\n* Women without a confirmed diagnosis of uterine fibroids (leiomyoma) through imaging.\n* Pregnant or breastfeeding women, or those planning to conceive during the study period.\n* Presence of chronic illnesses such as autoimmune diseases, cancers, or severe liver or kidney disease that could interfere with the study's outcomes.\n* Current or recent use of hormonal therapy, other vitamin D supplements, or medications that affect calcium metabolism or uterine fibroid growth (e.g., GnRH agonists, anti-estrogens).\n* Women who have undergone surgical interventions (e.g., myomectomy, hysterectomy) or other medical treatments specifically for uterine fibroid within the past 6 months.\n* Women with conditions like hyperparathyroidism or calcium disorders that might affect vitamin D metabolism or fibroid growth."}, 'identificationModule': {'nctId': 'NCT07012161', 'briefTitle': 'Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency', 'orgStudyIdInfo': {'id': '5256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pt with uterine fibroid', 'description': 'Study subjects will be selected according to inclusion and exclusion criteria, consents will be taken in informed written consent form, and then preceded as follow- 39 diagnosed women with uterine fibroid aged 18 to 50 years experiencing heavy menstrual bleeding will be purposively selected upon meeting the selection criteria Demographic information, medical history, clinical examination findings, and other relevant clinical data will be gathered through interviews Baseline Assessments: menstrual blood loss, hemoglobin concentration and ultrasound parameters (uterine volume, fibroid characteristics) Participants received 25(OH) Vitamin D3 orally', 'interventionNames': ['Drug: Colecalciferol (Vitamin D3) 50000 UI']}], 'interventions': [{'name': 'Colecalciferol (Vitamin D3) 50000 UI', 'type': 'DRUG', 'description': 'Participants will received vit d upto 6 months', 'armGroupLabels': ['Pt with uterine fibroid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'state': 'Sahabag', 'status': 'RECRUITING', 'country': 'Bangladesh', 'facility': 'Bangabandhu Sheikh Mujib medical university', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'city': 'Dhaka', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Prof.NurunNahar Khanam, Fcps,MS,DGO,MMED', 'role': 'CONTACT', 'phone': '+880 1713-017637'}], 'facility': 'Bangabandhu Sheikh Mujib medical university', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Nahida Akter, MBBS', 'role': 'CONTACT', 'email': 'nahidamili16@gmail.com', 'phone': '+8801635576296'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahida Akter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Nahida Akter', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}