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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroids; Epigallocatechin Gallate; Vitamin D; Inositol; D-chiro-inositol; Vitamin B6
• Intervention / Treatment: Dietary supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Massimo Stomati, Ph. D; Phone Number: 0831851303; Email: mstomati@gmail.com
• Study Contact Backup: Name: Andrea Tinelli, Ph. D; Phone Number: 0832394507; Email: andreatinelli@gmail.com

Study Locations

• Italy
  • Puglia
    • Francavilla Fontana, Puglia, Italy, 72021
      • Recruiting
      • Ospedale Dario camberlingo
      • Contact: Massimo Stomati, Ph.D; Email: mstomati@gmail.com
    • Scorrano, Puglia, Italy, 73020
      • Not yet recruiting
      • Ospedale Veris Delli Ponti
      • Contact: Andrea Tinelli, Ph. D; Email: andreatinelli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
2. eligible for surgery
3. symptoms like menometrorrhagia or pelvic pain

Exclusion Criteria:

1. BMI>30
2. currently pregnant or breastfeeding
3. diabetic
4. suspect of malignancy
5. diagnosis of cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter	Greater diameter of the diagnosed uterine fibroids	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Neuroprotective Agents; Protective Agents; Micronutrients; Bone Density Conservation Agents; Antioxidants; Vitamin B Complex; Anticarcinogenic Agents; Antimutagenic Agents; Vitamin D; Vitamins; Epigallocatechin gallate; Vitamin B 6; Pyridoxal; Pyridoxine; Inositol
• Other Study ID Numbers: DELPHYS PLUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No