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OpenTrials
Completed

NCT Number: NCT03991078

Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Vitamin D supplementation in patients with uterine fibroids who present hypovitaminosis D to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of Vitamin D on the myoma cells.

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Key information

Conditions

Size of the Uterine Fibroids

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fundacion IVI

Valencia, 46026, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with at least one fibroid > 3 cm
  • With hypovitaminosis D (25(OH)D < 30 ng/ml)
  • BMI < 30
  • No hormonal treatment in the 3 months prior to the ultrasound study

Exclusion criteria

  • Black race
  • Symptomatic fibroids subsidiary to hormonal or surgical treatment
  • Desire of gestation in the next 6 months
  • Presence of degenerating adenomyosis or fibroids
  • Treatment with sexual hormones: mifepristone, aGnRH or any other medication that may interfere with fibroids.
  • History of neoplasia of gynecological origin and/or existence of uterine malformations.
  • Hypercalcemia or abnormal liver or kidney function is present

Treatment and study plan

Primary outcomes

  1. volume of the uterine fibroids

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Fundación IVI

Other

Collaborators

  • Hospital Universitario La Fe

Registry information

Official study title

Pilot Clinical Study to Evaluate the Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2019
Registry last updated
Mar 13, 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.