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

Polycystic Ovary Syndrome Clinical Trial

— IALA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881851
• Other study ID #: CE10403
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: Universita di Verona
• Contact: Paolo Moghetti, Professor
• Phone: +39/0458123110
• Email: paolo.moghetti[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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
• Inositol
Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
• Folic acid (placebo comparator)
Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner

Locations

Country	Name	City	State
Italy	Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Laborest Italia SPA

Country where clinical trial is conducted

Italy, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free testosterone variation	Free testosterone variation after 6 months of treatment	6 months
Secondary	Insulin sensitivity variation	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
Secondary	Lipid profile variation	Lipid profile variation after 6 months of treatment	6 months
Secondary	Ovarian morphology variation	Ovarian morphology variation after 6 months of treatment	6 months
Secondary	Number of ovulations in the last 4 months of treatment	Number of ovulations in the last 4 months of treatment	4 months