Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
Study Overview
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
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
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.
Intervention: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol (Dietary Supplement)
Placebo
The subject takes the placebo twice a day for three months
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Volume of the larger fibroid(After 3 months of treatment)
- The proportion of patients who refuse surgery due to regression of symptoms.(After 3 months of treatment)
- The total score obtained in the Pad test(After 3 months of treatment)
- Proportion of patients who reported side effects or who stopped taking the treatment(After 3 months of treatment)
- The total score obtained in the Menstrual assessment chart(After 3 months of treatment)
- Quality of life (UFS-QoL questionnaire)(After 3 months of treatment)
Investigators
Stefano Uccella
Prof.
Universita di Verona