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NCT Number: NCT05409872

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

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

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Key information

Conditions

Leiomyoma, Uterine Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Verona, 37125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

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

Other

The subject takes the placebo twice a day for three months.

Primary outcomes

  1. Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)

    Time frame: 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 outcomes

  1. The proportion of patients who refuse surgery due to regression of symptoms.

    Time frame: After 3 months of treatment

    The proportion of patients who refuse surgery due to regression of symptoms.

  2. Volume of the larger fibroid

    Time frame: After 3 months of treatment

    Volume of the larger fibroid assessed by transvaginal ultrasound

  3. Quality of life (UFS-QoL questionnaire)

    Time frame: 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.

  4. The total score obtained in the Menstrual assessment chart

    Time frame: 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.

  5. The total score obtained in the Pad test

    Time frame: 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.

  6. Proportion of patients who reported side effects or who stopped taking the treatment

    Time frame: After 3 months of treatment

    Proportion of patients who reported side effects or who stopped taking the treatment

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Acronym: DEFIB

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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