Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)

NCT07298564 · Science & Research Islamic Azad University Branch Khozestan

Recruiting

In plain English

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Official title

Assessment of the Effect of Magnesium and Levocarnitine Co-supplementation on Lipid Profile, Glycemic Control Indicators and Hirsutism in Women With Polycystic Ovarian Syndrome

About this study

This is a randomized, triple-blind, parallel clinical trial evaluates the effects of co-supplementation with Magnesium and Levocarnitine on metabolic and hormonal outcomes in women with Polycystic Ovary Syndrome (PCOS). Patients are randomly assigned into three groups and received magnesium supplementation (500 mg/day, in two 250 mg doses), L-carnitine supplementation (1000 mg/day), and placebo for 12 weeks. Then the body mass index, waist circumference, systolic and diastolic blood pressure, Fasting Blood Sugar (FBS), lipid profile, Hemoglobin A1c (HbA1C), serum insulin concentration and insulin resistance are measured; All assessments will be performed at baseline and at the end of the study.

Eligibility criteria

Inclusion Criteria: * Age between 19 and 65 years. * Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. Exclusion Criteria: * Hypothyroidism * Menopause * Pregnancy or breastfeeding * Renal (kidney) dysfunction * Use of therapeutic vitamin or mineral supplements * Liver diseases (e.g., grade 3 fatty liver, hepatitis, or cirrhosis) * Psychiatric disorders such as bipolar disorder * Neuromuscular diseases (e.g., myasthenia gravis, Parkinson's disease, multiple sclerosis, epilepsy, or muscular dystrophy) * History of seizures * Participants who become pregnant during the study or fail to comply with more than 20% of the study protocol will be withdrawn from the study

Study design

Enrollment target: 84 participants

Allocation: randomized

Masking: triple

Age groups: adult, older_adult

Timeline

Starts: 2026-01-30

Estimated completion: 2026-11-30

Last updated: 2025-12-23

Interventions

Dietary Supplement: Magnesium 500 mgDietary Supplement: Levocarnitine 1000 mgDietary Supplement: PlaceboDietary Supplement: Magnesium 500 mgDietary Supplement: Placebo Levocarnitine

Primary outcomes

• Change from Baseline of FBS (Baseline and 12 weeks after)

Sponsor

Behnood Abbasi · other

Contacts & investigators

ContactBehnood Abbasi · contact · abbasi.b@srbiau.ac.ir · +9821 44864929

All locations (1)

Tara MomeniRecruiting

Tehran, Tehran Province, Iran

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