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

Universita di Verona108 enrolled

Overview

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

A randomized controlled trial aimed to evaluate the efficacy of a combination of Epigallocatechin gallate, vitamin D3, D-Chiro-inositol, and vitamin B6 as a treatment for uterine fibroids. The clinical study is double-blind, neither patients nor investigators know whether the subject receives the combination of Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 or the placebo. After 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Leiomyoma, Uterine

Interventions

Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositolDIETARY_SUPPLEMENT

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.

PlaceboOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, Italy

RECRUITING

Outcomes

Primary Outcomes

Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)

Symptoms related to uterine fibromatosis assessed with the eight symptom questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 8 - max 40, with higher scores meaning worse outcome.