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NCT Number: NCT05448365

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in 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.

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Key information

Conditions

Uterine Fibroids D-chiro-inositol Epigallocatechin Gallate Inositol Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Vitamin B6 Vitamin D

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Dario camberlingo, Francavilla Fontana, Apulia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • BMI>30
  • currently pregnant or breastfeeding
  • diabetic
  • suspect of malignancy
  • diagnosis of cancer

Treatment and study plan

Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

Dietary Supplement

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

Dietary Supplement

Maltodextrines

Primary outcomes

  1. Diameter

    Time frame: 3 months

    Greater diameter of the diagnosed uterine fibroids

Secondary outcomes

  1. Volume

    Time frame: 3 months

    Total volume of the diagnosed uterine fibroids

  2. Need for surgery

    Time frame: 3 months

    The percentage of patients that decide to avoid surgery

  3. pVEGF-R

    Time frame: 3 months

    the phosphorilation of VEGF receptor

  4. Marker of cellular proliferation

    Time frame: 3 months

    expression of ki67, ER, PR

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Tinelli, Ph. D

CONTACT

[email protected]

0832394507

Massimo Stomati, Ph. D

CONTACT

[email protected]

0831851303

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2022
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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