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

NCT ID: NCT03991078

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2024-12-25

Brief Summary

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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

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Conditions

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Size of the Uterine Fibroids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Fe

OTHER

Sponsor Role collaborator

Fundación IVI

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Pellicer, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación IVI

Locations

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Fundacion IVI

Valencia, , Spain

Site Status

Countries

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Spain

References

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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 Jun 5. doi: 10.1002/ijgo.70271. Online ahead of print.

Reference Type DERIVED
PMID: 40470887 (View on PubMed)

Other Identifiers

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1812-FIVI-100-AP

Identifier Type: REGISTRY

Identifier Source: secondary_id

IIS-COL-2018-01

Identifier Type: -

Identifier Source: org_study_id

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