NCT03991078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

June 17, 2019

Last Update Submit

March 11, 2025

Conditions

Size of the Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • volume of the uterine fibroids

    3 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with uterine fidroids and hypovitaminosis D

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion IVI

Valencia, 46026, Spain

Location

Related Publications (1)

  • Orive A, Corachan A, Escrig J, Mascarell-Lopez MDM, Pellicer A, Monleon J, Ferrero H. Effect of low-dose vitamin D supplementation on uterine fibroid size in women with hypovitaminosis D: A nonrandomized pilot study. Int J Gynaecol Obstet. 2025 Nov;171(2):720-727. doi: 10.1002/ijgo.70271. Epub 2025 Jun 5.

    PMID: 40470887DERIVED

Study Officials

  • Antonio Pellicer, PhD

    Fundación IVI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

July 9, 2019

Primary Completion

December 25, 2024

Study Completion

December 25, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

ES(1)