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

Leiomyoma, Uterine Clinical Trial

— DEFIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409872
• Other study ID #: DEFIB
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Universita di Verona
• Contact: Stefano Uccella, MD, PhD
• Phone: 0039 045 812 2720
• Email: stefano.uccella[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyoma, Uterine

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)	Symptoms related to uterine fibromatosis assessed with the eight symptom questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 8 - max 40, with higher scores meaning worse outcome.	After 3 months of treatment
Secondary	The proportion of patients who refuse surgery due to regression of symptoms.	The proportion of patients who refuse surgery due to regression of symptoms.	After 3 months of treatment
Secondary	Volume of the larger fibroid	Volume of the larger fibroid assessed by transvaginal ultrasound	After 3 months of treatment
Secondary	Quality of life (UFS-QoL questionnaire)	Quality of life assessed with the 29 health-related quality of life questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 29 - max 145, with higher scores meaning worse outcome.	After 3 months of treatment
Secondary	The total score obtained in the Menstrual assessment chart	The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome.	After 3 months of treatment
Secondary	The total score obtained in the Pad test	The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome.	After 3 months of treatment
Secondary	Proportion of patients who reported side effects or who stopped taking the treatment	Proportion of patients who reported side effects or who stopped taking the treatment	After 3 months of treatment