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

What this Trial Is About

Researchers are evaluating the effect of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol, and Vitamin B6 on the size of uterine fibroids in women aged 30 to 40 years. The study aims to compare changes in fibroid volume and diameter over a three-month period between women receiving the active supplement and those receiving a placebo. This trial is randomized and uses quadruple masking to ensure unbiased results. Participants will be randomly assigned to one of two groups: one group will take two tablets daily for three months, each containing 150 mg of Epigallocatechin gallate, 25 mg of D-chiro-inositol, 5 mg of Vitamin B6, and 25 mcg of Vitamin D; the other group will receive a placebo made of maltodextrins. The treatment period lasts three months with evaluations conducted at the start and after the treatment period. During the study, women will be assessed for fibroid diameter and volume, need for surgery, levels of pVEGF-R, and markers of cellular proliferation at baseline and after three months. Researchers will monitor these outcomes to understand the treatment's impact. The total study duration for participants is three months, during which their symptoms like menometrorrhagia or pelvic pain will also be considered.

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