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

Effect of Vitamin D3 Supplementation on Symptomatic Uterine Fibroid in Women With Vitamin D Deficiency

This trial will try giving vitamin D3 for six months to women with symptomatic uterine fibroids and low vitamin D to see if their symptoms and fibroid size improve.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Academic / other)
• Locations: 2 sites (Dhaka, Sahabag and 1 other locations)
• Trial ID: NCT07012161 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–50 with ultrasound-confirmed symptomatic uterine fibroids and serum 25(OH)D below 20 ng/mL who are not pregnant, not lactating, not planning pregnancy during the study, and not taking hormonal therapy or other vitamin D supplements are ideal candidates.

Not a fit: Women who have normal vitamin D levels, are postmenopausal, pregnant, planning pregnancy during the study, have serious comorbidities, or are taking medications that affect calcium metabolism or fibroid growth are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a low-cost, non-surgical option to reduce fibroid symptoms and possibly shrink fibroid size in vitamin D–deficient women.

How similar studies have performed: Preclinical work and a few small clinical reports suggest vitamin D can inhibit fibroid growth, but clinical evidence remains limited and not definitive.

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.

Where this trial is running

Dhaka, Sahabag and 1 other locations

• Bangabandhu Sheikh Mujib medical university — Dhaka, Sahabag, Bangladesh (Recruiting)
• Bangabandhu Sheikh Mujib medical university — Dhaka, Bangladesh (Recruiting)

Study contacts

• Study coordinator: Nahida Akter, MBBS

Conditions Symptomatic Uterine Fibroid