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

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ClinicalTrials.gov Identifier: NCT04881851
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
Laborest Italia SPA
Information provided by (Responsible Party):
Paolo Moghetti, Universita di Verona

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: Inositol + alpha lipoic acid Dietary Supplement: Inositol Dietary Supplement: Folic acid (placebo comparator) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, three-armed RCT
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
Actual Study Start Date : May 7, 2015
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024


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




Primary Outcome Measures :
  1. Free testosterone variation [ Time Frame: 6 months ]
    Free testosterone variation after 6 months of treatment


Secondary Outcome Measures :
  1. 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

  2. Lipid profile variation [ Time Frame: 6 months ]
    Lipid profile variation after 6 months of treatment

  3. Ovarian morphology variation [ Time Frame: 6 months ]
    Ovarian morphology variation after 6 months of treatment

  4. Number of ovulations in the last 4 months of treatment [ Time Frame: 4 months ]
    Number of ovulations in the last 4 months of treatment



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881851


Contacts
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Contact: Paolo Moghetti, Professor +39/0458123110 paolo.moghetti@univr.it

Locations
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Italy
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona Recruiting
Verona, Italy, 37126
Contact: Paolo Moghetti       paolo.moghetti@univr.it   
Sponsors and Collaborators
Universita di Verona
Laborest Italia SPA
Investigators
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Principal Investigator: Paolo Moghetti, Professor Università degli studi di Verona
Publications:

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Responsible Party: Paolo Moghetti, Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT04881851    
Other Study ID Numbers: CE10403
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in publications will be shared
Supporting Materials: Study Protocol
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Moghetti, Universita di Verona:
Inositol
alpha-lipoic acid
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Thioctic Acid
Inositol
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents