RecruitingNot ApplicableNCT05409872

Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids

Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial

Sponsor

Universita di Verona

Enrollment

108 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

Leiomyoma, Uterine

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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).

Exclusion Criteria7

Pregnancy.
Breastfeeding.
Smoking.
Suspected malignancy.
Patients who have undergone medical treatment for uterine fibroids within the previous three months.
Patients allergic to the components of the product or placebo under study.
Patients who refuse to provide informed consent to participate in the study.

Interventions

DIETARY_SUPPLEMENTCombination 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.

OTHERPlacebo

The subject takes the placebo twice a day for three months.