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

December 22, 2025 updated by: Behnood Abbasi

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

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age and is associated with metabolic abnormalities such as insulin resistance, dyslipidemia, and hormonal imbalance, which may lead to infertility and hirsutism. Despite the availability of several pharmacological treatments, many therapies fail to effectively address the underlying metabolic and endocrine dysfunctions of PCOS. Magnesium and L-carnitine are two essential nutrients that may play a synergistic role in improving insulin sensitivity, glucose metabolism, and lipid profile, as well as reducing oxidative stress and androgen production in women with PCOS. This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of co-supplementation with magnesium and L-carnitine on glycemic control indices, lipid profile, and hirsutism in women with PCOS. A total of 84 eligible women aged 19-65 years diagnosed with PCOS according to the Rotterdam criteria will be recruited from Shohada Tajrish Hospital, Tehran, Iran. Participants will be randomly assigned to one of three groups: (1) magnesium supplementation (500 mg/day, in two 250 mg doses) plus L-carnitine placebo, (2) L-carnitine supplementation (1000 mg/day) plus magnesium (500 mg/day), or (3) placebo control group. The intervention period will last 12 weeks. Physical activity information will be collected using short form of International Physical Activity Questionnaire (IPAQ) and demographic information through a general information questionnaire. In order to evaluate dietary intake of patients in terms of energy(kcal/(day), carbohydrate(gr/day), protein(gr/day), fat intake(gr/day), saturated fatty acids (SFA) (gr/day), monounsaturated fatty acids (MUFA) (gr/day), polyunsaturated fatty acids (PUFA)(gr/day), Vitamin E (mg/day), Vitamin C (mg/day), Beta-carotene (mg/day) and Vitamin A (mg/day), cupper intake (mg/day), selenium intake (mg/day), and zink intake (mg/day), 24-hr recalls will be completed by interviewing the patient for 3 days (two normal days and a weekend day). Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 0.5 centimeters. Then the body mass index will be calculated by dividing the weight (kg) by the square of the height (m), waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone (cm), systolic and diastolic blood pressure will be measured after 15 minutes of rest, twice using the mercuric barometric measure and the mean will be reported as individual blood pressure. The blood sample will be taken after 12 hours of overnight fasting in three groups for measuring Fasting Blood Sugar (FBS) (mg/dL), lipid profile (mg/dL), Hemoglobin A1c (HbA1C) (percentage), serum insulin concentration (µIU/ml) and insulin resistance. Insulin resistance will be calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) formula, and hirsutism score (using the modified Ferriman-Gallwey method) will be assessed at baseline and post-intervention. At the end of the study, counting the remaining capsules, the patient's compliance rate will be evaluated, and patients who have consumed less than 90% of their capsules will be excluded from the analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

84

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 Contact

Study Locations

  • Iran
    • Tehran Province
      • Tehran, Tehran Province, Iran

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium 500 mg and Placebo Levocarnitine
Magnesium 500Mg Oral Tablet and placebo matching Levocarnitine 1000 mg daily
Dietary supplement: Magnesium 500 mg

Participants will receive magnesium supplement 500 mg daily in two divided doses of 250 mg each for 12 weeks.

Magnesium Placebo

Dietary supplement: Magnesium 500 mg
Participants will receive magnesium 500 mg daily in two divided doses of 250 mg each for 12 weeks.
Dietary supplement: Placebo Levocarnitine
Participants will receive placebo matching Levocarnitine 1000 mg daily for 12 weeks.
Experimental: Levocarnitine 1000 mg and Magnesium 500 mg
Levocarnitine supplement 1000 mg daily, along with magnesium 500 mg daily in two divided doses of 250 mg
Dietary supplement: Magnesium 500 mg

Participants will receive magnesium supplement 500 mg daily in two divided doses of 250 mg each for 12 weeks.

Magnesium Placebo

Dietary supplement: Magnesium 500 mg
Participants will receive magnesium 500 mg daily in two divided doses of 250 mg each for 12 weeks.
Dietary supplement: Levocarnitine 1000 mg
Participants will receive Levocarnitine supplement 1000 mg daily for 12 weeks.
Placebo Comparator: Placebo
Placebo capsules matching magnesium and Levocarnitine for 12 weeks
Dietary supplement: Placebo
Participants will receive placebo capsules matching magnesium and Levocarnitine for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of FBS
Time Frame: Baseline and 12 weeks after
Fasting blood glucose concentration (mg/dl) (mg/dL)
Baseline and 12 weeks after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Triglyceride
Time Frame: Baseline and 12 weeks after
Serum TG (triacylglycerol) concentration (mg/dl)
Baseline and 12 weeks after
Change from baseline of total cholesterol
Time Frame: Baseline and 12 weeks after
Serum TC (total cholesterol) concentration (mg/dl)
Baseline and 12 weeks after
Change from Baseline of serum insulin
Time Frame: Baseline and 12 weeks after
Serum insulin (µIU/mL)
Baseline and 12 weeks after
Change from baseline of HbA1c
Time Frame: Baseline and 12 weeks after
Baseline and 12 weeks after
Change from baseline of HOMA-IR
Time Frame: Baseline and 12 weeks after
Calculated as [fasting glucose (mg/dL) × fasting insulin (µIU/mL) / 405]
Baseline and 12 weeks after
Change from baseline of low density lipoprotein cholesterol (LDL-Cholesterol)
Time Frame: Baseline and 12 weeks after
Serum LDL concentration (mg/dl)
Baseline and 12 weeks after
Change from baseline of high density lipoprotein cholesterol (HDL-Cholesterol)
Time Frame: Baseline and 12 weeks after
Serum HDL concentration (mg/dl)
Baseline and 12 weeks after

Collaborators and Investigators

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

Sponsor

Behnood Abbasi

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 (Estimated)

January 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 6, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IAU.SRB.REC.1404.234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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