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

This study is currently recruiting participants.
Verified April 2012 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01574261
First received: April 6, 2012
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
 Drug: Placebo
Drug: Inositol
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Inositol
U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • CD4+ CD28 null T-lymphocyte frequency [ Time Frame: five minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • insulinaemic area OGTT AUCi, lipid profile, androgen levels [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574261

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

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

Publications:

Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01574261     History of Changes
Other Study ID Numbers: disfunzionale12
Study First Received: April 6, 2012
Last Updated: April 9, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Catholic University of the Sacred Heart:
Polycystic Ovary Syndrome
Cardiovascular risk
Metabolic Syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013