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Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626443
First Posted: June 22, 2012
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l
  Purpose

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.

The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.


Condition Intervention Phase
PCOS Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid Dietary Supplement: Folic acid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Lo.Li.Pharma s.r.l:

Primary Outcome Measures:
  • Menstrual cycle restoration [ Time Frame: At 6 months ]
  • Score hirsutism (Ferriman-Gallwey classification) [ Time Frame: At 6 months ]
  • Serum progesterone [ Time Frame: At 6 months ]
  • Testosterone level test [ Time Frame: At 6 months ]
  • Oral glucose tolerance test (OGTT) [ Time Frame: At 6 months ]
    Evaluation of glycemia and insulinemia levels

  • Homeostasis Model Assessment (HOMA-index) [ Time Frame: At 6 months ]
  • Sex hormone binding globulin (SHBG) test [ Time Frame: At 6 months ]
  • Androstenediol level test [ Time Frame: At 6 months ]
  • Androstenedione level test [ Time Frame: At 6 months ]
  • Free Androgen Index (FAI) level test [ Time Frame: At 6 months ]

Secondary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: At 6 months ]
  • Change from baseline in diastolic blood pressure levels [ Time Frame: At 6 months ]
  • Change from baseline in systolic blood pressure levels [ Time Frame: At 6 months ]
  • Number of patients with abnormal ovarian size and morphology [ Time Frame: At 6 months ]
    Ovarian ultrasound scan for the assessment of size and morphology

  • Luteinizing Hormone (LH) level test [ Time Frame: At 6 months ]
    Analysis of LH levels should be performed between the 7th and the 10th day of the cycle

  • Follicle Stimulating Hormone (FSH) level test [ Time Frame: At 6 months ]
    Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle

  • Estradiol (E2) level test [ Time Frame: At 6 months ]
    Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle


Enrollment: 46
Actual Study Start Date: January 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Folic acid Dietary Supplement: Folic acid
Folic acid (200 mcg); 2 x die
Experimental: Inofolic Combi Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid
Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS
  • Women aged between 14-40 years
  • BMI > 28
  • Hyperinsulinemia

Exclusion Criteria:

  • Pre-existing secondary endocrine and metabolic disorders
  • Pre-existing secondary adrenal disorders
  • Pharmacologic treatment in the last 3 months before entering the study
  • Pregnancy
  Contacts and Locations
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): NCT01626443


Locations
Italy
University of Pisa - Department of Endocrinology
Pisa, Italy
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
  More Information

Publications:
Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT01626443     History of Changes
Other Study ID Numbers: MI-DCI
First Submitted: June 15, 2012
First Posted: June 22, 2012
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Lo.Li.Pharma s.r.l:
PCOS
Metabolic disorders
Ovarian functionality
Myo-inositol
D-chiro-inositol

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Inositol
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs