Leiomyoma, UterineDEFIBNCT05409872
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids
A study testing Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol in people with Leiomyoma, Uterine, run by Universita di Verona at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma, Uterine
- What is being tested?
- Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2022to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125
About this study
Official title: Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
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
Read the 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.
- Conditions
- Leiomyoma, Uterine
- Being tested
- Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol, Placebo
- Keywords
- Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositolDietary supplement
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.
PlaceboOther
The subject takes the placebo twice a day for three months.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol | Experimental | 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. Receives: Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol |
| Placebo | Placebo comparator | The subject takes the placebo twice a day for three months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 months of treatment
Secondary outcomes (6)
The proportion of patients who refuse surgery due to regression of symptoms.
The proportion of patients who refuse surgery due to regression of symptoms.
Measured: After 3 months of treatment
Volume of the larger fibroid
Volume of the larger fibroid assessed by transvaginal ultrasound
Measured: After 3 months of treatment
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.
Measured: After 3 months of treatment
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.
Measured: After 3 months of treatment
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.
Measured: After 3 months of treatment
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
Measured: After 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Sep 2022
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Leiomyoma, UterineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1) double-blind, single-center controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Universita di Verona
- Investigators
- Stefano Uccella, MD, PhD, Principal investigator, AOUI Verona - University of VeronaSimone Garzon, MD, Principal investigator, AOUI Verona - University of VeronaPier Carlo Zorzato, MD, Principal investigator, AOUI Verona - University of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409872
- Sponsor's protocol ID
- DEFIB
- Acronym
- DEFIB
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23493030Roshdy 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.
PubMed 23950663Porcaro 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.
PubMed 32271452Zhang 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.
PubMed 19819432
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05409872
- Acronym / sponsor ID
- DEFIB / DEFIB
- Conditions
- Leiomyoma, Uterine
- Keywords
- Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1) double-blind, single-center controlled trial
| Arm | Type | Receives |
|---|---|---|
| Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol | Experimental | Dietary Supplement: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositolThe 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 | Placebo comparator | Other: PlaceboThe subject takes the placebo twice a day for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- Pregnancy.
- Breastfeeding.
- Smoking.
- Suspected malignancy.
- Patients who have undergone medical treatment for uterine fibroids within the previous three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositolThe 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 |
| PlaceboThe subject takes the placebo twice a day for three months. | Other | Placebo |
Primary outcome
Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
Time frame: 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.
6 secondary outcomes
The proportion of patients who refuse surgery due to regression of symptoms.
Time frame: After 3 months of treatment
Volume of the larger fibroid
Time frame: After 3 months of treatment
Quality of life (UFS-QoL questionnaire)
Time frame: After 3 months of treatment
The total score obtained in the Menstrual assessment chart
Time frame: After 3 months of treatment
The total score obtained in the Pad test
Time frame: After 3 months of treatment
Proportion of patients who reported side effects or who stopped taking the treatment
Time frame: After 3 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 23493030Baird 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.
- Background: PubMed 23950663Roshdy 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.
- Background: PubMed 32271452Porcaro 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.
- Background: PubMed 19819432Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Uccella, MD, PhD principal investigator
AOUI Verona - University of Verona
Simone Garzon, MD principal investigator
AOUI Verona - University of Verona
Pier Carlo Zorzato, MD principal investigator
AOUI Verona - University of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol in people with Leiomyoma, Uterine, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms related to uterine fibromatosis (UFS-QoL questionnaire) (time frame: After 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409872, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.