Efficacy of Trace Elements in the Treatment of Endometriosis: a Pilot Study

Efficacy of Food Supplements Containing Trace Elements in the Treatment of Endometriosis, Combined or Not to an Adenomyosis: a Pilot Study

The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: ENDO 1/ENDO 2

Detailed Description

The objectives of this pilot study are to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain, on the quality of life, on the use of rescue medication (ibuprofen) in patients with an endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. The safety of trace elements versus placebo will also be assessed.

This will be a prospective, interventional, randomized, placebo-controlled, two parallel-group, double-blind study.

Trace elements or placebo are administered in the absence of any other treatment or as add-on treatments to common therapies such as sexual hormones, anti-inflammatory drugs or surgery.

A run-in placebo period of 30 days will allow eliminating the patients who are responding to strongly to a placebo.

The treatment will last for 4 months. The total duration of the study will be 5 months for each patient. Four medical visits (Days -45 to -30, 0, 60 and 120) and two phone contacts (Days 30 and 90) will be scheduled.

A urine pregnancy test will be undertaken at each visit. The quality of life scale (EHP-30) will be filled in on Days 0, 60 and 120. During the whole study period, patients will be asked to fill in a diary, in which they will score their pain on a visual analog scale, their blood loss and their consumption of rescue medication (ibuprofen).

Phone contacts will be used to reinforce the compliance and to collect potential adverse events.

Non-serious and serious adverse events will be collected between Days 0 and 120.

All concomitant medications will be recorded, including the rescue medication between Day -45 and Day 120.

A paper case report form will be used.

A total of 60 patients (30 receiving trace elements and 30 receiving placebo) will be randomized to achieve a total of 50 patients.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Hainaut
    • Montigny-le-Tilleul, Hainaut, Belgium, 6110
      • CHU Vésale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Written informed consent
• Woman suffering from an AFSr 2 to 4 endometriosis (combined or not to an adenomyosis), confirmed by laparoscopy, laparotomy or MRI as well as by a biopsy (done within 3 years before inclusion in the study), treated or not with sexual hormones, contraceptive or not (stable treatment for minimum 2 months) or any other treatment
• Time period of at least 6 months after surgical treatment
• Age between 18 and 45 years
• Non-menopausal woman
• Baseline pain (Day -45 to -30) of at least 40 mm on a visual analog scale
• No reduction of more than 20% of pain on the visual analog scale after the run-in placebo period.

Exclusion Criteria:

• AFSr 1 endometriosis
• Adenomyosis without endometriosis
• Pregnancy
• Existence of another pathology that could interfere with endometriosis and/or with adenomyosis, and the study follow-up
• Psychological or psychiatric conditions
• Patient who, according to the investigator, will not be able to comply to the prerequisites of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.	Dietary supplement: Placebo; Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
Experimental: Trace elements; NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.	Dietary supplement: ENDO 1/ENDO 2; NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (visual analog scale)	Pain scored daily by the patient using a visual analog scale	Day 0 to Day 120

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EHP-30 (validated 30-items questionnaire)	Quality of life determined using a validated 30-items questionnaire (EHP-30)	Day 0 to Day 120
Rescue medication consumption (Number of ibuprofen tablets consumed)		Day 0 to Day 120
Safety (Non-serious and serious adverse events (related or not)	Non-serious and serious adverse events (related or not)	Day 0 to Day 120

Collaborators and Investigators

• Sponsor: Laboratoires Pronutri
• Collaborators: Expert Clinical Services Organization (ECSOR)
• Investigators: Principal Investigator: Didier Oberweis, MD, CHU Vésale

Publications and helpful links

Helpful Links

• A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; pelvic pain; adenomyosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: Pronutri-IIIa-001

Plan for Individual participant data (IPD)

Study Data/Documents

1. Methodology paper