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

Coordinación de Investigación en Salud, Mexico

Status: Terminated

Conditions: Polycystic Ovary Syndrome; Obesity

Treatments: Dietary Supplement: Magnesium; Drug: Metformin; Dietary Supplement: PUFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02521753

R-2014-785-056

Details and patient eligibility

About

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.

Full description

Polycystic Ovary Syndrome (PCOS)

Enrollment: 123 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 3 patient groups

Metformin

Active Comparator group

Description:

Metformin 850mg twice a day for six months

Treatment:

Drug: Metformin

Magnesium

Experimental group

Description:

Magnesium chloride 250mg daily for six months

Treatment:

Dietary Supplement: Magnesium

PUFA omega 3

Experimental group

Description:

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

Treatment:

Dietary Supplement: PUFA