FATIMA Trial: EGCG and Vitamin D3 for Prevention of Fibroid Recurrence
ConditionUterine Fibroids (Leiomyoma)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSheikh Shakhbout Medical City
About this trial
The aim of this randomized controlled clinical trial is to evaluate the efficacy of green tea (EGCG) and vitamin D3 supplementation in preventing uterine fibroid recurrence following fibroid removal.
Eligibility criteria
Qualifiers
Has voluntarily signed and dated the informed consent form before initiation of any screening or study-specific procedures.
Premenopausal females aged 18 years and older on the day of signing of the informed consent form.
Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period.
Moderate to heavy menses defined as PBAC score ≥ 120
Disqualifiers
Participants with documented vitamin D deficiency (based on previous serum vitamin D level within prior 12 months).
Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps > 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.
Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle.
Has undergone ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, as well as endometrial ablation for abnormal uterine bleeding within 6 months prior to the screening visit.
Trial design
Treatments tested in this trial
- Vitamin D and Green Tea
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov