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

Primary Purpose

Leiomyoma, Uterine

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Placebo
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma, Uterine focused on measuring Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • AOUI Verona - University of Verona - Department of Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm 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.

The subject takes the placebo twice a day for three months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2022
Last Updated
April 1, 2023
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT05409872
Brief Title
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
Acronym
DEFIB
Official Title
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine
Keywords
Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized (1:1) double-blind, single-center controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subject takes the placebo twice a day for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The subject takes the placebo twice a day for three months.
Primary Outcome Measure Information:
Title
Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
Description
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.
Time Frame
After 3 months of treatment
Secondary Outcome Measure Information:
Title
The proportion of patients who refuse surgery due to regression of symptoms.
Description
The proportion of patients who refuse surgery due to regression of symptoms.
Time Frame
After 3 months of treatment
Title
Volume of the larger fibroid
Description
Volume of the larger fibroid assessed by transvaginal ultrasound
Time Frame
After 3 months of treatment
Title
Quality of life (UFS-QoL questionnaire)
Description
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.
Time Frame
After 3 months of treatment
Title
The total score obtained in the Menstrual assessment chart
Description
The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome.
Time Frame
After 3 months of treatment
Title
The total score obtained in the Pad test
Description
The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome.
Time Frame
After 3 months of treatment
Title
Proportion of patients who reported side effects or who stopped taking the treatment
Description
Proportion of patients who reported side effects or who stopped taking the treatment
Time Frame
After 3 months of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Uccella, MD, PhD
Phone
0039 045 812 2720
Email
stefano.uccella@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Garzon, MD
Phone
0039 045 812 2720
Email
simone.garzon@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Uccella, MD, PhD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Garzon, MD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pier Carlo Zorzato, MD
Organizational Affiliation
AOUI Verona - University of Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
City
Verona
ZIP/Postal Code
37125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Garzon, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23493030
Citation
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.
Results Reference
background
PubMed Identifier
23950663
Citation
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.
Results Reference
background
PubMed Identifier
32271452
Citation
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.
Results Reference
background
PubMed Identifier
19819432
Citation
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.
Results Reference
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Learn more about this trial

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

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