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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leiomyoma, Uterine

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized (1:1) double-blind, single-center controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>The subject takes the placebo twice a day for three months | Other: Placebo<br>* The subject takes the placebo twice a day for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who refuse surgery due to regression of symptoms. | The proportion of patients who refuse surgery due to regression of symptoms. | After 3 months of treatment | 
| Volume of the larger fibroid | Volume of the larger fibroid assessed by transvaginal ultrasound | After 3 months of treatment | 
| 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. | After 3 months of treatment | 
| 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. | After 3 months of treatment | 
| 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. | After 3 months of treatment | 
| 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 | After 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6