NCT05409872

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Leiomyoma, Uterine

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol	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.
OTHER	Placebo	The subject takes the placebo twice a day for three months.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-06-08
• Last updated: 2025-03-04

Locations

1 site across 1 country: Italy