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

Last updated: May 31, 2025
Sponsor: Nahida Akter
Overall Status: Active - Recruiting

Phase

1

Condition

Desmoid Tumors

Uterine Fibroids

Sarcoma (Pediatric)

Treatment

Colecalciferol (Vitamin D3) 50000 UI

Clinical Study ID

NCT07012161
5256
  • Ages 18-50
  • Female

Study 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 Criteria

Inclusion

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 Ddeficiency).

  • Presence of symptoms associated with uterine fibroid, such as menorrhagia (heavymenstrual bleeding), or bulk-related symptoms (e.g., urinary frequency).

  • Participants should be generally healthy, with no history of other chronic illnessesthat could affect the study's outcomes (e.g., autoimmune diseases, cancers, severeliver 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 medicationsknown to influence calcium metabolism or uterine fibroid growth (e.g., GnRHagonists, anti-estrogens).

  • Participants must be willing and able to adhere to the study protocol, includingattending follow-up visits and completing any required assessments or tests.

Exclusion

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 studyperiod.

  • Presence of chronic illnesses such as autoimmune diseases, cancers, or severe liveror kidney disease that could interfere with the study's outcomes.

  • Current or recent use of hormonal therapy, other vitamin D supplements, ormedications that affect calcium metabolism or uterine fibroid growth (e.g., GnRHagonists, anti-estrogens).

  • Women who have undergone surgical interventions (e.g., myomectomy, hysterectomy) orother medical treatments specifically for uterine fibroid within the past 6 months.

  • Women with conditions like hyperparathyroidism or calcium disorders that mightaffect vitamin D metabolism or fibroid growth.

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Colecalciferol (Vitamin D3) 50000 UI
Phase: 1
Study Start date:
February 20, 2025
Estimated Completion Date:
September 30, 2026

Study Description

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

Connect with a study center

  • Bangabandhu Sheikh Mujib medical university

    Dhaka, Sahabag
    Bangladesh

    Active - Recruiting

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