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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT01626443
First received: June 15, 2012
Last updated: February 13, 2017
Last verified: February 2017
  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: No masking

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 15, 2012
Last Updated: February 13, 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

ClinicalTrials.gov processed this record on March 28, 2017