Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms related to uterine fibroids
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy.
• Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization.
• Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS).
Locations
Other Locations
Italy
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
RECRUITING
Verona
Contact Information
Primary
Stefano Uccella, MD, PhD
stefano.uccella@univr.it
0039 045 812 2720
Backup
Simone Garzon, MD
simone.garzon@univr.it
0039 045 812 2720
Time Frame
Start Date: 2022-09-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 108
Treatments
Experimental: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
The subject takes a combination of 333.35 mg of green tea extract (150 mg of Epigallocatechin gallate), 25 mg of D-Chiro-inositol, 25 mcg of Vitamin D, and 5 mg of Vitamin B6 twice a day for three months.
Placebo_comparator: Placebo
The subject takes the placebo twice a day for three months
Related Therapeutic Areas
Sponsors
Leads: Universita di Verona