Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedNovember 3, 2010
August 1, 2009
August 5, 2009
November 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial structure and function
six months
Secondary Outcomes (1)
Clinical outcome Metabolic outcome Endocrine outcome
six months
Study Arms (2)
Folate
EXPERIMENTALFolate plus metformin
Placebo
PLACEBO COMPARATORPlacebo plus metformin
Interventions
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
Eligibility Criteria
You may qualify if:
- PCOS
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"Pugliese" Hospital
Catanzaro, Italy
Related Publications (1)
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.
PMID: 19933994RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 6, 2009
Study Start
January 1, 2004
Study Completion
May 1, 2007
Last Updated
November 3, 2010
Record last verified: 2009-08