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

L

Lo.Li.Pharma

Status and phase

Completed
Phase 4

Conditions

PCOS

Treatments

Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid
Dietary Supplement: Folic acid

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

Female

Ages

14 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

46 participants in 2 patient groups

Folic acid
Active Comparator group
Treatment:
Dietary Supplement: Folic acid
Inofolic Combi
Experimental group
Treatment:
Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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