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NCT Number: NCT07012161

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

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..

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Bangabandhu Sheikh Mujib medical university, Dhaka, Sahabag, Bangladesh

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colecalciferol (Vitamin D3) 50000 UI

Drug

Participants will received vit d upto 6 months

Primary outcomes

  1. Effect of Vitamin D3 supplementation on symptomatic uterine fibroid in women with Vitamin D deficiency.

    Time frame: 18 months

    Fibroid size by cm

Study contacts

Contact information is provided by the study sponsor or research team.

Nahida Akter, MBBS

CONTACT

[email protected]

+8801635576296

Sponsors and collaborators

Lead sponsor

Nahida Akter

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.