Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome Anovulation |
Drug: Folate plus metformin Drug: Placebo plus metformin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome |
- Endothelial structure and function [ Time Frame: six months ] [ Designated as safety issue: No ]
- Clinical outcome Metabolic outcome Endocrine outcome [ Time Frame: six months ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | January 2004 |
| Study Completion Date: | May 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Folate
Folate plus metformin
|
Drug: Folate plus metformin
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
|
|
Placebo Comparator: Placebo
Placebo plus metformin
|
Drug: Placebo plus metformin
A six-month course of metformin (1700 mg daily) plus placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00953355 History of Changes |
| Other Study ID Numbers: | 07/009 |
| Study First Received: | August 5, 2009 |
| Last Updated: | November 2, 2010 |
| Health Authority: | Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Anovulation Polycystic Ovary Syndrome Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Ovarian Cysts Cysts Neoplasms Folic Acid |
Vitamin B Complex Metformin Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 16, 2013