DEFIB: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
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.
|
Placebo Comparator: Placebo The subject takes the placebo twice a day for three months |
Other: Placebo
The subject takes the placebo twice a day for three months.
|
Outcome Measures
Primary Outcome Measures
- Symptoms related to uterine fibromatosis (UFS-QoL questionnaire) [After 3 months of treatment]
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.
Secondary Outcome Measures
- The proportion of patients who refuse surgery due to regression of symptoms. [After 3 months of treatment]
The proportion of patients who refuse surgery due to regression of symptoms.
- Volume of the larger fibroid [After 3 months of treatment]
Volume of the larger fibroid assessed by transvaginal ultrasound
- Quality of life (UFS-QoL questionnaire) [After 3 months of treatment]
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.
- The total score obtained in the Menstrual assessment chart [After 3 months of treatment]
The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome.
- The total score obtained in the Pad test [After 3 months of treatment]
The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome.
- Proportion of patients who reported side effects or who stopped taking the treatment [After 3 months of treatment]
Proportion of patients who reported side effects or who stopped taking the treatment
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | AOUI Verona - University of Verona - Department of Obstetrics and Gynecology | Verona | Italy | 37125 |
Sponsors and Collaborators
- Universita di Verona
Investigators
- Principal Investigator: Stefano Uccella, MD, PhD, AOUI Verona - University of Verona
- Principal Investigator: Simone Garzon, MD, AOUI Verona - University of Verona
- Principal Investigator: Pier Carlo Zorzato, MD, AOUI Verona - University of Verona
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- DEFIB