Effect of Vitamin D on the Size of Fibroids in Women With... | NCT03991078

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

NCT03991078

Sponsor

Fundación IVI

Status

Completed

Last Update Posted

Mar 13, 2025Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Size of the Uterine Fibroids

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1812-FIVI-100-AP	Registry Identifier	UAGI

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2019Actual

Primary Completion Date

Dec 25, 2024Actual

Completion Date

Dec 25, 2024Actual

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 18, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

Name	Class
Hospital Universitario La Fe	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Measure	Description	Time Frame
volume of the uterine fibroids		3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients with uterine fidroids and hypovitaminosis D

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Pellicer, PhD	Fundación IVI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion IVI		Valencia		46026	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40470887	Derived	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.