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TerminatedNCT02521753OMgObPCOSUpdated Apr 1, 2025

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

An interventional study of Metformin and Magnesium in Polycystic Ovary Syndrome and Obesity, sponsored by Coordinación de Investigación en Salud, Mexico. Terminated at 1 site in Mexico. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Coordinación de Investigación en Salud, Mexico · Not applicable, Interventional, and Treatment

Why this study was terminated
It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published
Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
01

Study summary

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.

Read the detailed description

Polycystic Ovary Syndrome (PCOS)

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Obesity

Keywords

  • Polycystic ovary syndrome
  • Obesity
  • Metformin
  • Magnesium
  • Polyunsaturated fatty acids
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 123 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Coordinación de Investigación en Salud, Mexico is the lead sponsor of 95 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Type 2 diabetes mellitus,
  • in treatment for polycystic ovary syndrome features
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Active comparator
    Metformin

    Metformin 850mg twice a day for six months

    Drug: Metformin

  • Experimental
    Magnesium

    Magnesium chloride 250mg daily for six months

    Dietary Supplement: Magnesium

  • Experimental
    PUFA omega 3

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

    Dietary Supplement: PUFA

Interventions

  • DrugMetformin

    Intervention also includes weight reduction diet and exercise therapy

    Also known as: Glucophage

  • Dietary supplementMagnesium

    Intervention also includes weight reduction diet and exercise therapy

    Also known as: Nature made magnesium

  • Dietary supplementPUFA

    Intervention also includes weight reduction diet and exercise therapy

    Also known as: Omega 3

06

What researchers measure

Primary outcomes

  1. Metabolic profile

    Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)

    Time frame: Six months after intervention

Secondary outcomes

  1. Hormonal profile

    Serum concentration of hormones \[Testosterone, dehydroepiandrosterone sulphate (DHEAs), sex hormone-binding globulin (SHBG), free androgen index (FAI)\]

    Time frame: Six months after intervention

07

Study locations

1 site
  • Hospital de Gineco Obstetricia Centro Médico "La Raza"
    Mexico City, D.f. 2990, Mexico
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to share data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02521753
Lead sponsor
Coordinación de Investigación en Salud, Mexico
Responsible party
Mardia Guadalupe Lopez Alarcon (Investigador titular B, Coordinación de Investigación en Salud, Mexico) — Principal investigator
First posted
Aug 13, 2015
Start date
Aug 2015
Primary completion
Aug 2020
Completion
Mar 2025
Last update
Apr 1, 2025

Study contacts

Mardia Guadalupe López Alarcón, MD, phD
principal investigator · Instituto Mexicano del Seguro Social

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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