Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05448365

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.

The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids D-chiro-inositol Inositol Epigallocatechin Gallate Vitamin D Vitamin B6	Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol Dietary Supplement: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Women with uterine fibroidsWomen with uterine fibroids

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The study will be a double-clind, placebp-controlled trial

Primary Purpose:

Treatment

Official Title:

The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EGCG, Vit D, DCI, Vit B6 Women with uterine fibroids randomized to treatment group	Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D
Placebo Comparator: Placebo Women with uterine fibroids randomized to placebo group	Dietary Supplement: Placebo Maltodextrines

Arm

Intervention/Treatment

Active Comparator: EGCG, Vit D, DCI, Vit B6

Women with uterine fibroids randomized to treatment group

Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D

Placebo Comparator: Placebo

Women with uterine fibroids randomized to placebo group

Dietary Supplement: Placebo

Maltodextrines

Outcome Measures

Primary Outcome Measures

Diameter [3 months]
Greater diameter of the diagnosed uterine fibroids

Secondary Outcome Measures

Volume [3 months]
Total volume of the diagnosed uterine fibroids
Need for surgery [3 months]
The percentage of patients that decide to avoid surgery
pVEGF-R [3 months]
the phosphorilation of VEGF receptor
Marker of cellular proliferation [3 months]
expression of ki67, ER, PR