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

Not Applicable

Recruiting

• Conditions: Leiomyoma, Uterine
• Interventions: Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol; Other: Placebo

• Registration Number: NCT05409872
• Lead Sponsor: Universita di Verona

Brief 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

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 Timeline

• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-08
• Study Start: 2022-09-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol	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	Placebo	The subject takes the placebo twice a day for three months

Primary Outcome Measures

Name	Time	Method
Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)	After 3 months of treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology; 🇮🇹 Verona, Italy