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

March 11, 2025 updated by: Fundación IVI

Pilot Clinical Study to Evaluate the 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Fundacion IVI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with uterine fidroids and hypovitaminosis D

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
volume of the uterine fibroids
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación IVI

Collaborators

Hospital Universitario La Fe

Investigators

  • Principal Investigator: Antonio Pellicer, PhD, Fundacion IVI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

December 25, 2024

Study Completion (Actual)

December 25, 2024

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIS-COL-2018-01
  • 1812-FIVI-100-AP (Registry Identifier: UAGI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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