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

NCT04881851 | Terminated

• 1 other identifier: CE10403
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inositol; alpha-lipoic acid

Outcome Measures

Primary Outcomes (1)

• Free testosterone variation

  Free testosterone variation after 6 months of treatment

  6 months

Secondary Outcomes (4)

• Insulin sensitivity variation

  6 months

• Lipid profile variation

  6 months

• Ovarian morphology variation

  6 months

• Number of ovulations in the last 4 months of treatment

  4 months

Study Arms (3)

Inositol + alpha lipoic acid

EXPERIMENTAL

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

EXPERIMENTAL

Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Dietary Supplement: Inositol

Folic acid

PLACEBO COMPARATOR

Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Dietary Supplement: Folic acid (placebo comparator)

Interventions

Inositol + alpha lipoic acid DIETARY_SUPPLEMENT

Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Inositol + alpha lipoic acid

Inositol DIETARY_SUPPLEMENT

Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Inositol

Folic acid (placebo comparator) DIETARY_SUPPLEMENT

Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Folic acid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universita di Verona: lead
• Laborest Italia SPA: collaborator

Study Sites (1)

Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona

Verona, 37126, Italy

Location

Related Publications (33)

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MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol; Thioctic Acid; Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paolo Moghetti, Professor

  Università degli studi di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blinded, three-armed RCT

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: May 7, 2015
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available when the study will be completed. They will remain available for 3 years.
• Access Criteria: Upon specified request.

Locations

IT (1)