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

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

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

Study Overview

• Status: Completed
• Conditions: Leiomyoma, Uterine
• Intervention / Treatment: Dietary supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37125
    • AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: 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	Other: Placebo; The subject takes the placebo twice a day for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 3 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who refuse surgery due to regression of symptoms.	The proportion of patients who refuse surgery due to regression of symptoms.	After 3 months of treatment
Volume of the larger fibroid	Volume of the larger fibroid assessed by transvaginal ultrasound	After 3 months of treatment
Quality of life (UFS-QoL questionnaire)	Quality of life assessed with the 29 health-related quality of life questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 29 - max 145, with higher scores meaning worse outcome.	After 3 months of treatment
The total score obtained in the Menstrual assessment chart	The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome.	After 3 months of treatment
The total score obtained in the Pad test	The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome.	After 3 months of treatment
Proportion of patients who reported side effects or who stopped taking the treatment	Proportion of patients who reported side effects or who stopped taking the treatment	After 3 months of treatment

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Stefano Uccella, MD, PhD, AOUI Verona - University of Verona; Principal Investigator: Simone Garzon, MD, AOUI Verona - University of Verona; Principal Investigator: Pier Carlo Zorzato, MD, AOUI Verona - University of Verona

Publications and helpful links

General Publications

• Baird DD, Hill MC, Schectman JM, Hollis BW. Vitamin d and the risk of uterine fibroids. Epidemiology. 2013 May;24(3):447-53. doi: 10.1097/EDE.0b013e31828acca0.
• Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, Al-Hendy A. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013.
• Porcaro G, Santamaria A, Giordano D, Angelozzi P. Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas. Eur Rev Med Pharmacol Sci. 2020 Mar;24(6):3344-3351. doi: 10.26355/eurrev_202003_20702.
• Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Rajaratnam V, Al-Hendy A. Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. Fertil Steril. 2010 Oct;94(5):1887-93. doi: 10.1016/j.fertnstert.2009.08.065. Epub 2009 Oct 12.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): April 28, 2026
• Study Completion (Actual): April 28, 2026

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Vitamin D; Vitamin B6; Epigallocatechin gallate; Leiomyoma, Uterine; D-Chiro-inositol
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Secosteroids; Picolines; Vitamin D; Vitamin B 6
• Other Study ID Numbers: DEFIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No