Size of the Uterine Fibroids Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | December 25, 2024 |
| Est. primary completion date | December 25, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Fundacion IVI | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación IVI | Hospital Universitario La Fe |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | volume of the uterine fibroids | 3 months |