Back to resultsVitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
Primary Purpose
Uterine Fibroids, D-chiro-inositol, Inositol
Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
Eligibility Criteria
Inclusion Criteria:
- uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
- eligible for surgery
- symptoms like menometrorrhagia or pelvic pain
Exclusion Criteria:
- BMI>30
- currently pregnant or breastfeeding
- diabetic
- suspect of malignancy
- diagnosis of cancer
Sites / Locations
- Ospedale Dario camberlingoRecruiting
- Ospedale Veris Delli Ponti
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
EGCG, Vit D, DCI, Vit B6
Placebo
Arm Description
Women with uterine fibroids randomized to treatment group
Women with uterine fibroids randomized to placebo group
Outcomes
Primary Outcome Measures
Diameter
Greater diameter of the diagnosed uterine fibroids
Secondary Outcome Measures
Volume
Total volume of the diagnosed uterine fibroids
Need for surgery
The percentage of patients that decide to avoid surgery
pVEGF-R
the phosphorilation of VEGF receptor
Marker of cellular proliferation
expression of ki67, ER, PR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448365
Brief Title
Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
Official Title
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.
The patients will be evaluated at baseline and after three months of treatment with placebo or product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, D-chiro-inositol, Inositol, Epigallocatechin Gallate, Vitamin D, Vitamin B6
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Women with uterine fibroids
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be a double-clind, placebp-controlled trial
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGCG, Vit D, DCI, Vit B6
Arm Type
Active Comparator
Arm Description
Women with uterine fibroids randomized to treatment group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Women with uterine fibroids randomized to placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
Intervention Description
The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrines
Primary Outcome Measure Information:
Title
Diameter
Description
Greater diameter of the diagnosed uterine fibroids
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Volume
Description
Total volume of the diagnosed uterine fibroids
Time Frame
3 months
Title
Need for surgery
Description
The percentage of patients that decide to avoid surgery
Time Frame
3 months
Title
pVEGF-R
Description
the phosphorilation of VEGF receptor
Time Frame
3 months
Title
Marker of cellular proliferation
Description
expression of ki67, ER, PR
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
eligible for surgery
symptoms like menometrorrhagia or pelvic pain
Exclusion Criteria:
BMI>30
currently pregnant or breastfeeding
diabetic
suspect of malignancy
diagnosis of cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Stomati, Ph. D
Phone
0831851303
Email
mstomati@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Tinelli, Ph. D
Phone
0832394507
Email
andreatinelli@gmail.com
Facility Information:
Facility Name
Ospedale Dario camberlingo
City
Francavilla Fontana
State/Province
Puglia
ZIP/Postal Code
72021
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Stomati, Ph.D
Email
mstomati@gmail.com
Facility Name
Ospedale Veris Delli Ponti
City
Scorrano
State/Province
Puglia
ZIP/Postal Code
73020
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Tinelli, Ph. D
Email
andreatinelli@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
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