Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment (IALA)

May 25, 2021 updated by: Paolo Moghetti, Universita di Verona

The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS).

The study population is composed of 90 women with PCOS (diagnosed according to the Rotterdam criteria). Subjects are randomized to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone).

At recruitment and after 6 months of treatment, the following data are collected:

  • clinical data: height, weight, BMI, waist and hip circumference, blood pressure, Ferriman Gallwey Score, menstrual diary
  • endocrine parameters (serum total and free testosterone levels, SHBG levels)
  • metabolic profile: glycemia and insulinemia at fasting and after oral glucose tolerance test (OGTT), serum lipids
  • insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
  • ovarian ultrasound data. Furthermore, ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples.

The primary outcome of the study is the serum free testosterone variation after 6 months of treatment. Secondary outcomes are the variations of lipid profile, ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha-lipoic acid, in women with PCOS. This is a double blinded, three-armed RCT.

The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona.

After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18<BMI<25, 25≥BMI<30, 30≥BMI<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1.

At baseline and after 6 months of treatment, the following data are collected:

  • clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman-Gallwey score)
  • total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea
  • metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL-cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
  • insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline (M-value < 8.6 mg/kg min).
  • Chronic inflammation markers (CRP)
  • Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona.

Furthermore, all the study participants are subjected to:

  • ovulation assessment by serial progesterone dosages on weekly urinary samples. Patients are given numbered urine beakers and are instructed to collect night urine weekly, starting at the 3rd month of treatment and until the end of the study (17 samples).

  • monitoring visits after 2 and 4 months of treatment, to evaluate therapy compliance and possible adverse events.

    30 ml blood samples of the study participants will be preserved for 10 years. On these samples, further examinations will be considered if new important markers of PCOS will emerge in the future.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Verona, Italy, 37126
        • Recruiting
        • Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female subjects
  • age between 18 and 40 years old
  • diagnosed with PCOS (according to the Rotterdam criteria)
  • not use of possible interfering drugs in the 4 previous months
  • written informed consent.

Exclusion Criteria:

  • BMI ≥ 35 kg/m2
  • acute illnesses
  • chronic kidney or hepatic disease
  • pregnant
  • taking possible interfering drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inositol + alpha lipoic acid
Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Dietary supplement: Inositol + alpha lipoic acid
Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Experimental: Inositol
Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Dietary supplement: Inositol
Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Placebo Comparator: Folic acid
Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Dietary supplement: Folic acid (placebo comparator)
Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free testosterone variation
Time Frame: 6 months
Free testosterone variation after 6 months of treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity variation
Time Frame: 6 months
Insulin sensitivity variation after 6 months of treatment, evaluated by surrogate indexes in all the subjects and by repeating hyperinsulinemic euglycemic clamp after 6 months of treatment in women that are insulin-resistant at baseline
6 months
Lipid profile variation
Time Frame: 6 months
Lipid profile variation after 6 months of treatment
6 months
Ovarian morphology variation
Time Frame: 6 months
Ovarian morphology variation after 6 months of treatment
6 months
Number of ovulations in the last 4 months of treatment
Time Frame: 4 months
Number of ovulations in the last 4 months of treatment
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Collaborators

Laborest Italia SPA

Investigators

  • Principal Investigator: Paolo Moghetti, Professor, Universita Degli Studi Di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2015

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE10403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All individual participant data (IPD) that underlie results in publications will be shared

IPD Sharing Time Frame

Data will become available when the study will be completed. They will remain available for 3 years.

IPD Sharing Access Criteria

Upon specified request.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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