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

NCT07298564 | Recruiting

• 1 other identifier: IR.IAU.SRB.REC.1404.234
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome; Hyperandrogenism; Insulin Resistance; Dyslipidemia; Hirsutism

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of FBS

  Fasting blood glucose concentration (mg/dl) (mg/dL)

  Baseline and 12 weeks after

Secondary Outcomes (7)

• Change from Baseline of serum insulin

  Baseline and 12 weeks after

• Change from baseline of HbA1c

  Baseline and 12 weeks after

• Change from baseline of HOMA-IR

  Baseline and 12 weeks after

• Change from baseline of total cholesterol

  Baseline and 12 weeks after

• Change from baseline of Triglyceride

  Baseline and 12 weeks after

Study Arms (3)

Magnesium 500 mg and Placebo Levocarnitine

EXPERIMENTAL

Magnesium 500Mg Oral Tablet and placebo matching Levocarnitine 1000 mg daily

Dietary Supplement: Magnesium 500 mg; Dietary Supplement: Placebo Levocarnitine

Levocarnitine 1000 mg and Magnesium 500 mg

EXPERIMENTAL

Levocarnitine supplement 1000 mg daily, along with magnesium 500 mg daily in two divided doses of 250 mg

Dietary Supplement: Levocarnitine 1000 mg; Dietary Supplement: Magnesium 500 mg

Placebo

PLACEBO COMPARATOR

Placebo capsules matching magnesium and Levocarnitine for 12 weeks

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Participants will receive placebo capsules matching magnesium and Levocarnitine for 12 weeks.

Placebo

Placebo Levocarnitine DIETARY_SUPPLEMENT

Participants will receive placebo matching Levocarnitine 1000 mg daily for 12 weeks.

Magnesium 500 mg and Placebo Levocarnitine

Magnesium 500 mg DIETARY_SUPPLEMENT

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

Magnesium 500 mg and Placebo Levocarnitine

Levocarnitine 1000 mg DIETARY_SUPPLEMENT

Participants will receive Levocarnitine supplement 1000 mg daily for 12 weeks.

Levocarnitine 1000 mg and Magnesium 500 mg

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 and 65 years.
• Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.

You may not qualify if:

• 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

Sponsors & Collaborators

• Behnood Abbasi: lead

Study Sites (1)

Tara Momeni

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Insulin Resistance; Dyslipidemias; Hirsutism

Interventions

Magnesium; Carnitine

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Central Study Contacts

Behnood Abbasi

CONTACT

+9821 44864929; abbasi.b@srbiau.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study is designed as a triple-blind randomized controlled trial. Participants, care providers, and investigators responsible for data collection and intervention administration will be blinded to group allocation. Before the study, containers will be coded as A, B and C by a person other than the study researchers according the concealment rules .The supplements (magnesium, L-carnitine, and placebo) will be identical in appearance, taste, and packaging, and labeled with coded numbers by an independent pharmacist who is not involved in the study procedures or data analysis. Group codes will be kept sealed until the completion of data analysis. This approach ensures the concealment of allocation and minimizes performance and detection bias throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a randomized, parallel-group interventional study designed to evaluate the effects of magnesium and levocarnitine co-supplementation on metabolic and clinical parameters in women with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to one of three parallel groups: (1) magnesium supplementation plus placebo levocarnitine , (2) levocarnitine and magnesium co-supplementation, or (3) placebo. The intervention period lasts 12 weeks, and outcomes include lipid profile, glycemic control, and hirsutism severity.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 23, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)