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

Not Applicable

Recruiting

• Conditions: Uterine Fibroids; Inositol; Epigallocatechin Gallate; Vitamin B6; D-chiro-inositol; Vitamin D
• Interventions: Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol; Dietary Supplement: Placebo

• Registration Number: NCT05448365
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGCG, Vit D, DCI, Vit B6	Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol	Women with uterine fibroids randomized to treatment group
Placebo	Placebo	Women with uterine fibroids randomized to placebo group

Primary Outcome Measures

Name	Time	Method
Diameter	3 months	Greater diameter of the diagnosed uterine fibroids

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ospedale Dario camberlingo; 🇮🇹 Francavilla Fontana, Puglia, Italy

Ospedale Veris Delli Ponti; 🇮🇹 Scorrano, Puglia, Italy