Clinical trial NCT07012161: Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
Official title: Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Symptomatic Uterine Fibroid
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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..

Detailed description: Effects of vitamin D supplimentation on symptomatic uterine fibroid will be checked

Eligibility criteria: Inclusion Criteria:

.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 Criteria:

* 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.

Primary outcomes:
measure: Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib medical university
state: Sahabag
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib medical university
Study officials:
References: