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

Last updated: February 27, 2025
Sponsor: Universita di Verona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Desmoid Tumors

Sarcoma (Pediatric)

Uterine Fibroids

Treatment

Placebo

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

Clinical Study ID

NCT05409872
DEFIB
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who arecandidates for hysterectomy.

  • Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who arecandidates for myomectomy / uterine arterial embolization.

  • Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who arecandidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS).

Exclusion

Exclusion Criteria:

  • Pregnancy.

  • Breastfeeding.

  • Smoking.

  • Suspected malignancy.

  • Patients who have undergone medical treatment for uterine fibroids within theprevious 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.

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
September 15, 2022
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

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

    Verona, 37125
    Italy

    Active - Recruiting

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