Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol, Placebo.
- Who it may be relevant to
- Registry conditions: Uterine Fibroids, D-chiro-inositol, Inositol, Epigallocatechin Gallate. Basic parameters: 30 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
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 - Dietary supplement Placebo
Maltodextrines
Primary outcome measures
- Diameter [Time frame: 3 months]
Secondary outcome measures (4)
- Volume [Time frame: 3 months]
- Need for surgery [Time frame: 3 months]
- pVEGF-R [Time frame: 3 months]
- Marker of cellular proliferation [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- Ospedale Dario camberlingo — Francavilla Fontana
- Ospedale Veris Delli Ponti — Scorrano
Identifiers
NCT: NCT05448365 · DELPHYS PLUS