Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
NCT ID: NCT05409872
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2022-09-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Placebo
The subject takes the placebo twice a day for three months
Placebo
The subject takes the placebo twice a day for three months.
Interventions
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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.
Placebo
The subject takes the placebo twice a day for three months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Universita di Verona
OTHER
Responsible Party
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Stefano Uccella
Prof.
Principal Investigators
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Stefano Uccella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AOUI Verona - University of Verona
Simone Garzon, MD
Role: PRINCIPAL_INVESTIGATOR
AOUI Verona - University of Verona
Pier Carlo Zorzato, MD
Role: PRINCIPAL_INVESTIGATOR
AOUI Verona - University of Verona
Locations
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AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Simone Garzon, MD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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DEFIB
Identifier Type: -
Identifier Source: org_study_id
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