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

Sponsor
Universita di Verona (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05409872
Collaborator
(none)
108
1
2
6
18

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
  • Other: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized (1:1) double-blind, single-center controlled trialRandomized (1:1) double-blind, single-center controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination 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.

Dietary Supplement: Combination 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.

Placebo Comparator: Placebo

The subject takes the placebo twice a day for three months

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

Outcome Measures

Primary Outcome Measures

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

  1. The proportion of patients who refuse surgery due to regression of symptoms. [After 3 months of treatment]

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

  2. Volume of the larger fibroid [After 3 months of treatment]

    Volume of the larger fibroid assessed by transvaginal ultrasound

  3. Quality of life (UFS-QoL questionnaire) [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 [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 [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 [After 3 months of treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOUI Verona - University of Verona - Department of Obstetrics and Gynecology Verona Italy 37125

Sponsors and Collaborators

  • Universita di Verona

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stefano Uccella, Prof., Universita di Verona
ClinicalTrials.gov Identifier:
NCT05409872
Other Study ID Numbers:
  • DEFIB
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Stefano Uccella, Prof., Universita di Verona
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022