Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency
Completed
- Conditions
- Size of the Uterine Fibroids
- Registration Number
- NCT03991078
- Lead Sponsor
- Fundación IVI
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method volume of the uterine fibroids 3 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Vitamin D's anti-proliferative effects on uterine myoma cells in NCT03991078?
How does Vitamin D supplementation compare to standard-of-care treatments for fibroid size reduction in hypovitaminosis D patients?
Which biomarkers correlate with response to Vitamin D therapy in uterine fibroid management according to NCT03991078?
What adverse events are associated with high-dose Vitamin D regimens in women with uterine fibroids and vitamin D deficiency?
Are there combination therapies involving Vitamin D and aromatase inhibitors showing enhanced efficacy in reducing fibroid size?
Trial Locations
- Locations (1)
Fundacion IVI
🇪🇸Valencia, Spain
Fundacion IVI🇪🇸Valencia, Spain