MedTrace Logo

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

NCT04881851 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

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

DIETARY_SUPPLEMENT

Inositol

Inositol 1000 mg + 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

Sponsors & Collaborators

  • Laborest Italia SPA

    collaborator UNKNOWN

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Paolo Moghetti, Professor · Università degli studi di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-07
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881851 on ClinicalTrials.gov