Size of the Uterine FibroidsNCT03991078
Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency
An observational study of Size of the Uterine Fibroids, run by Fundación IVI at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Size of the Uterine Fibroids
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jul 2019to 25 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with uterine fidroids and hypovitaminosis D
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Size of the Uterine Fibroids
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of the uterine fibroids
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start9 Jul 2019
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Size of the Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Sponsor
- Investigators
- Antonio Pellicer, PhD, Principal investigator, Fundación IVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991078
- Sponsor's protocol ID
- IIS-COL-2018-01
- Other IDs
- 1812-FIVI-100-AP
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2019
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40470887
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study to Evaluate the Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT03991078
- Acronym / sponsor ID
- IIS-COL-2018-01
- Conditions
- Size of the Uterine Fibroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with uterine fidroids and hypovitaminosis D
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
volume of the uterine fibroids
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40470887Orive 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Pellicer, PhD principal investigator
Fundación IVI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Size of the Uterine Fibroids, run by Fundación IVI at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of the uterine fibroids (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.