NCT01626443

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Lo.Li.Pharma s.r.l · Industry
• Sex: Female
• Age: 14 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PCOS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-06-22
• Last updated: 2017-02-14

Locations

1 site across 1 country: Italy