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Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

Primary Purpose

Polycystic Ovary Syndrome, Anovulation

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Folate plus metformin

Placebo plus metformin

About this trial

This is an interventional prevention trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

PCOS

Exclusion Criteria:

age <18 or >35 years
BMI >35 kg/m2
neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Sites / Locations

"Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Folate

Placebo

Arm Description

Folate plus metformin

Placebo plus metformin

Outcomes

Primary Outcome Measures

Endothelial structure and function

Secondary Outcome Measures

Clinical outcome Metabolic outcome Endocrine outcome

Full Information

NCT ID

NCT00953355

First Posted

August 5, 2009

Last Updated

November 2, 2010

Sponsor

University Magna Graecia

1. Study Identification

Unique Protocol Identification Number

NCT00953355

Brief Title

Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

Official Title

Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Magna Graecia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin. Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Detailed Description

Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms. Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation. In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Anovulation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Folate

Arm Type

Experimental

Arm Description

Folate plus metformin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo plus metformin

Intervention Type

Drug

Intervention Name(s)

Folate plus metformin

Intervention Description

A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).

Intervention Type

Drug

Intervention Name(s)

Placebo plus metformin

Intervention Description

A six-month course of metformin (1700 mg daily) plus placebo

Primary Outcome Measure Information:

Title

Endothelial structure and function

Time Frame

six months

Secondary Outcome Measure Information:

Title

Clinical outcome Metabolic outcome Endocrine outcome

Time Frame

six months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PCOS Exclusion Criteria: age <18 or >35 years BMI >35 kg/m2 neoplastic, metabolic, hepatic, renal, and cardiovascular disorders Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Facility Information:

Facility Name

"Pugliese" Hospital

City

Catanzaro

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19933994

Citation

Palomba S, Falbo A, Giallauria F, Russo T, Tolino A, Zullo F, Colao A, Orio F. Effects of metformin with or without supplementation with folate on homocysteine levels and vascular endothelium of women with polycystic ovary syndrome. Diabetes Care. 2010 Feb;33(2):246-51. doi: 10.2337/dc09-1516. Epub 2009 Nov 23.

Results Reference

result

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Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

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