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

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ClinicalTrials.gov Identifier: NCT01574261
Recruitment Status : Unknown
Verified April 2012 by Rosanna Apa, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2012
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arms and Interventions
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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
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Primary Outcome Measures :
  1. CD4+ CD28 null T-lymphocyte frequency [ Time Frame: five minutes ]

Secondary Outcome Measures :
  1. insulinaemic area OGTT AUCi, lipid profile, androgen levels [ Time Frame: 120 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574261


Contacts
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Contact: Rosanna Apa, M.D.; PhD 00390630155872 sandrina84@hotmail.com

Locations
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Italy
Università cattolica S. Cuore Recruiting
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
More Information
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Publications of Results:

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Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01574261    
Other Study ID Numbers: disfunzionale12
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Rosanna Apa, Catholic University of the Sacred Heart:
Polycystic Ovary Syndrome
Cardiovascular risk
Metabolic Syndrome
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Gonadal Disorders
Endocrine System Diseases
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs