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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
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
  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:


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
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: 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
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014