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New treatment option for Symptomatic Uterine Fibroid
Official title Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency
ClinicalTrials.gov ID: NCT07012161
What this study is testing
What is Colecalciferol (Vitamin D3) 50000 UI?
Colecalciferol (Vitamin D3) 50000 UI is an investigational medicine, being studied as a potential treatment for symptomatic uterine fibroid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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..
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- .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...
- Participants should be generally healthy, with no history of other chronic illnesses that could affect the study's outcomes (e.g., autoimmune...
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Sahabag, Bangladesh
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Sahabag, Bangladesh; Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.