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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of natural supplements — vitamin D, EGCG (a compound from green tea), vitamin B6, and D-chiro-inositol — can reduce the size of uterine fibroids (non-cancerous growths in the uterus) in women who are already scheduled for surgery or another procedure to treat them. **You may be eligible if...** - You are a woman with multiple fibroids or a single fibroid that is 4 cm or larger - You are scheduled for hysterectomy, myomectomy, uterine artery embolization, or focused ultrasound treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You smoke - There is a suspicion of cancer - You have recently received hormonal or other medical treatment for fibroids (e.g., GnRH analogues) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

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

Verona, Italy

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NCT05409872


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