Clinical trial NCT05409872: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
Official title: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leiomyoma, Uterine
Keywords: Leiomyoma, Uterine
Epigallocatechin gallate
Vitamin D
D-Chiro-inositol
Vitamin B6
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1) double-blind, single-center controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy.
* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization.
* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS).

Exclusion Criteria:

* Pregnancy.
* Breastfeeding.
* Smoking.
* Suspected malignancy.
* Patients who have undergone medical treatment for uterine fibroids within the previous three months.
* Patients allergic to the components of the product or placebo under study.
* Patients who refuse to provide informed consent to participate in the study.

Primary outcomes:
measure: Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
timeFrame: After 3 months of treatment
Secondary outcomes:
measure: The proportion of patients who refuse surgery due to regression of symptoms.
timeFrame: After 3 months of treatment
measure: Volume of the larger fibroid
timeFrame: After 3 months of treatment
measure: Quality of life (UFS-QoL questionnaire)
timeFrame: After 3 months of treatment
measure: The total score obtained in the Menstrual assessment chart
timeFrame: After 3 months of treatment
measure: The total score obtained in the Pad test
timeFrame: After 3 months of treatment
measure: Proportion of patients who reported side effects or who stopped taking the treatment
timeFrame: After 3 months of treatment
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Study officials:
affiliation: AOUI Verona - University of Verona
name: Stefano Uccella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOUI Verona - University of Verona
name: Simone Garzon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOUI Verona - University of Verona
name: Pier Carlo Zorzato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baird DD, Hill MC, Schectman JM, Hollis BW. Vitamin d and the risk of uterine fibroids. Epidemiology. 2013 May;24(3):447-53. doi: 10.1097/EDE.0b013e31828acca0.
citation: Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, Al-Hendy A. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013.
citation: Porcaro G, Santamaria A, Giordano D, Angelozzi P. Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas. Eur Rev Med Pharmacol Sci. 2020 Mar;24(6):3344-3351. doi: 10.26355/eurrev_202003_20702.
citation: Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Rajaratnam V, Al-Hendy A. Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. Fertil Steril. 2010 Oct;94(5):1887-93. doi: 10.1016/j.fertnstert.2009.08.065. Epub 2009 Oct 12.