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

NCT ID: NCT02521753

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Polycystic Ovary Syndrome (PCOS)

Conditions

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Polycystic Ovary Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The study is open label. No blindness for participant or investigator is used

Study Groups

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Metformin

Metformin 850mg twice a day for six months

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Intervention also includes weight reduction diet and exercise therapy

Magnesium

Magnesium chloride 250mg daily for six months

Group Type EXPERIMENTAL

Magnesium

Intervention Type DIETARY_SUPPLEMENT

Intervention also includes weight reduction diet and exercise therapy

PUFA omega 3

Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months

Group Type EXPERIMENTAL

PUFA

Intervention Type DIETARY_SUPPLEMENT

Intervention also includes weight reduction diet and exercise therapy

Interventions

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Metformin

Intervention also includes weight reduction diet and exercise therapy

Intervention Type DRUG

Magnesium

Intervention also includes weight reduction diet and exercise therapy

Intervention Type DIETARY_SUPPLEMENT

PUFA

Intervention also includes weight reduction diet and exercise therapy

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Glucophage Nature made magnesium Omega 3

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mardia Guadalupe Lopez Alarcon

Investigador titular B

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mardia Guadalupe López Alarcón, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

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Hospital de Gineco Obstetricia Centro Médico "La Raza"

Mexico City, D.F., Mexico

Site Status

Countries

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Mexico

Other Identifiers

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R-2014-785-056

Identifier Type: -

Identifier Source: org_study_id

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