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

U

University of Verona

Status

Enrolling

Conditions

Leiomyoma, Uterine

Treatments

Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

108 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

108 participants in 2 patient groups, including a placebo group

Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Placebo
Placebo Comparator group
Description:
The subject takes the placebo twice a day for three months
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Simone Garzon, MD; Stefano Uccella, MD, PhD

Data sourced from clinicaltrials.gov

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