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

NCT05409872 | Completed DMC

• 1 other identifier: DEFIB
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Leiomyoma, Uterine

Keywords

Leiomyoma, Uterine; Epigallocatechin gallate; Vitamin D; D-Chiro-inositol; Vitamin B6

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  After 3 months of treatment

• Volume of the larger fibroid

  After 3 months of treatment

• Quality of life (UFS-QoL questionnaire)

  After 3 months of treatment

• The total score obtained in the Menstrual assessment chart

  After 3 months of treatment

• The total score obtained in the Pad test

  After 3 months of treatment

Study Arms (2)

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

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

The subject takes the placebo twice a day for three months

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

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

Verona, 37125, Italy

Location

Related Publications (4)

• 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.

  PMID: 23493030 BACKGROUND

• 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.

  PMID: 23950663 BACKGROUND

• 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.

  PMID: 32271452 BACKGROUND

• 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.

  PMID: 19819432 BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Interventions

Vitamin D; Vitamin B 6

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Randomized (1:1) double-blind, single-center controlled trial

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: September 15, 2022
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)