Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients (OMgObPCOS)

March 27, 2025 updated by: Mardia Guadalupe Lopez Alarcon, Coordinación de Investigación en Salud, Mexico

Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Polycystic Ovary Syndrome (PCOS)

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.f.
      • Mexico City, D.f., Mexico, 2990
        • Hospital de Gineco Obstetricia Centro Médico "La Raza"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Polycystic Ovary Syndrome according to Rotterdam criteria,
  • BMI ≥ 27 Kg/m2

Exclusion Criteria:

  • Type 2 diabetes mellitus,
  • in treatment for polycystic ovary syndrome features

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
Metformin 850mg twice a day for six months
Drug: Metformin
Intervention also includes weight reduction diet and exercise therapy
Other Names:
  • Glucophage
Experimental: Magnesium
Magnesium chloride 250mg daily for six months
Dietary supplement: Magnesium
Intervention also includes weight reduction diet and exercise therapy
Other Names:
  • Nature made magnesium
Experimental: PUFA omega 3
Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months
Dietary supplement: PUFA
Intervention also includes weight reduction diet and exercise therapy
Other Names:
  • Omega 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic profile
Time Frame: Six months after intervention
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)
Six months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormonal profile
Time Frame: Six months after intervention
Serum concentration of hormones [Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)]
Six months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Mardia Guadalupe López Alarcón, MD, phD, Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimated)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2014-785-056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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