Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

• Sponsor: Catholic University of the Sacred Heart (Other)
• Overall Status: Completed
• CT.gov ID: NCT01555190
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Hirsutism; Menstrual Irregularity	Drug: myo-inositol 1500 gr; Drug: myo-inositol 2000 gr + folic acid 200 mcg	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: myo-inositol 1500 gr 6 months treatment with myo-inositol 1500 gr	Drug: myo-inositol 1500 gr
Active Comparator: myo-inositol 2000gr + folic acid 200 mcg	Drug: myo-inositol 2000 gr + folic acid 200 mcg

Outcome Measures

Primary Outcome Measures

1. number of cycles in six months of therapy [6 months]

   We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.

Secondary Outcome Measures

1. effects on oral glucose tollerance test [six months]

2. effects on hoormonal assay [6 months]

3. effects oon lipide profile [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003

• BMI > 25 kg/m2

• age 18-35 years

Exclusion Criteria:

• pregnancy

• significant liver or renal impairment

• other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)

• neoplasms

• unstable mental illness

• diagnosis of diabetes mellitus or impaired glucose tolerance

• use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of Sacred Heart	Rome		Italy	00168

Sponsors and Collaborators

• Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Guido, medical doctor, Catholic University of the Sacred Heart
• ClinicalTrials.gov Identifier: NCT01555190
• Other Study ID Numbers: 000102012
• First Posted: Mar 15, 2012
• Last Update Posted: Jul 24, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Maurizio Guido, medical doctor, Catholic University of the Sacred Heart: myo-inositol; folic acid
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Hirsutism; Syndrome; Menstruation Disturbances; Folic Acid; Inositol

Study Results

No Results Posted as of Jul 24, 2020