Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT01574261

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Placebo Drug: Inositol	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inositol Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment	Drug: Inositol Inositol 4g/die for four months
Placebo Comparator: Placebo Patients will be randomized to receive placebo for four months	Drug: Placebo Placebo for four months

Arm

Intervention/Treatment

Active Comparator: Inositol

Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment

Drug: Inositol

Inositol 4g/die for four months

Placebo Comparator: Placebo

Patients will be randomized to receive placebo for four months

Drug: Placebo

Placebo for four months

Outcome Measures

Primary Outcome Measures

CD4+ CD28 null T-lymphocyte frequency [five minutes]

Secondary Outcome Measures

insulinaemic area OGTT AUCi, lipid profile, androgen levels [120 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Polycystic Ovary Syndrome
Age >18 and <35

Exclusion Criteria:

Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).