Vitamin D3 for symptomatic uterine fibroids in women with vitamin D deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Thirty-nine women with ultrasound-confirmed symptomatic uterine fibroids and serum 25(OH)D levels below 20 ng/mL will receive oral colecalciferol (vitamin D3, 50,000 IU) for six months. Symptoms such as heavy menstrual bleeding and bulk-related complaints will be recorded and fibroid size will be measured by ultrasound before and after treatment. Participants must be 18–50 years old, not pregnant or lactating, and not taking hormonal therapies or other vitamin D supplements. The trial is conducted at Bangabandhu Sheikh Mujib Medical University in Dhaka with scheduled in-person follow-up visits over the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bangabandhu Sheikh Mujib medical university
  Dhaka, Sahabag, Bangladesh Recruiting
• Bangabandhu Sheikh Mujib medical university
  Dhaka, Bangladesh Recruiting

Study contacts

• Study coordinator: Nahida Akter, MBBS
• Email: nahidamili16@gmail.com
• Phone: +8801635576296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.