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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Lo.Li.Pharma s.r.l.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT01626443
First received: June 15, 2012
Last updated: October 18, 2012
Last verified: June 2012

June 15, 2012
October 18, 2012
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Not Provided
  • Menstrual cycle restoration
  • Score hirsutism (Ferriman-Gallwey classification)
  • Serum progesterone
  • Testosterone level test
  • Oral glucose tolerance test (OGTT)
    Evaluation of glycemia and insulinemia levels
  • Homeostasis Model Assessment (HOMA-index)
  • Sex hormone binding globulin (SHBG) test
  • Androstenediol level test
  • Androstenedione level test
  • Free Androgen Index (FAI) level test
Same as current
Complete list of historical versions of study NCT01626443 on ClinicalTrials.gov Archive Site
  • Body Mass Index (BMI) [ Time Frame: three and six months ]
  • Change from baseline in diastolic blood pressure levels [ Time Frame: three and six months ]
  • Change from baseline in systolic blood pressure levels [ Time Frame: three and six months ]
  • Number of patients with abnormal ovarian size and morphology
    Ovarian ultrasound scan for the assessment of size and morphology
  • Luteinizing Hormone (LH) level test
    Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
  • Follicle Stimulating Hormone (FSH) level test
    Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
  • Estradiol (E2) level test
    Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
Same as current
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Not Provided
 
Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
Not Provided

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.

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Interventional
Phase 4
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PCOS
  • 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
  • Dietary Supplement: Folic acid
    Folic acid (200 mcg); 2 x die
  • Active Comparator: Folic acid
    Intervention: Dietary Supplement: Folic acid
  • Experimental: Inofolic Combi
    Intervention: Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

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
Female
14 Years to 40 Years
No
Contact: Elena Bonelli elena684@interfree.it
Italy
 
NCT01626443
MI-DCI
Not Provided
Lo.Li.Pharma s.r.l
Lo.Li.Pharma s.r.l
Not Provided
Not Provided
Lo.Li.Pharma s.r.l
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP