RecruitingEarly Phase 1NCT07012161
Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
Sponsor
Nahida Akter
Enrollment
39 participants
Start Date
Feb 20, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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..
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years
Inclusion Criteria8
- Women aged between 18-50 not currently pregnant, lactating, or planning to conceive during the study period.
- Women with a confirmed diagnosis of uterine fibroids (leiomyoma) through ultrasound.
- Serum 25-hydroxyvitamin D \[25(OH)D\] levels below 20 ng/mL (indicating vitamin D deficiency).
- Presence of symptoms associated with uterine fibroid, such as menorrhagia (heavy menstrual bleeding), or bulk-related symptoms (e.g., urinary frequency).
- 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).
- Willingness to provide written informed consent for participation in the study.
- 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).
- Participants must be willing and able to adhere to the study protocol, including attending follow-up visits and completing any required assessments or tests.
Exclusion Criteria8
- Women younger than 18 or older than 50 years.
- Serum 25-hydroxyvitamin D \[25(OH)D\] levels of 20 ng/mL or higher.
- Women without a confirmed diagnosis of uterine fibroids (leiomyoma) through imaging.
- Pregnant or breastfeeding women, or those planning to conceive during the study period.
- Presence of chronic illnesses such as autoimmune diseases, cancers, or severe liver or kidney disease that could interfere with the study's outcomes.
- 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).
- Women who have undergone surgical interventions (e.g., myomectomy, hysterectomy) or other medical treatments specifically for uterine fibroid within the past 6 months.
- Women with conditions like hyperparathyroidism or calcium disorders that might affect vitamin D metabolism or fibroid growth.
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Interventions
DRUGColecalciferol (Vitamin D3) 50000 UI
Participants will received vit d upto 6 months
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07012161