Magnesium plus L-carnitine for metabolic and hormonal symptoms in women with PCOS
Assessment of the Effect of Magnesium and Levocarnitine Co-supplementation on Lipid Profile, Glycemic Control Indicators and Hirsutism in Women With Polycystic Ovarian Syndrome
This 12-week test will see if taking magnesium together with L-carnitine improves blood sugar, cholesterol, and excess hair in women aged 19–65 with PCOS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | Female |
| Sponsor | Science & Research Islamic Azad University Branch Khozestan Academic / other |
| Locations | 1 site (Tehran, Tehran Province) |
| Trial ID | NCT07298564 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, parallel-group trial will enroll 84 women aged 19–65 diagnosed with PCOS by Rotterdam criteria and randomly assign them to magnesium (500 mg/day), L-carnitine (1000 mg/day), or placebo for 12 weeks. Primary measurements include BMI, waist circumference, blood pressure, fasting blood sugar, HbA1c, lipid profile, serum insulin, calculated insulin resistance, and hirsutism, taken at baseline and at the end of the intervention. Key exclusions include pregnancy or breastfeeding, menopause, hypothyroidism, significant liver or kidney disease, seizure or neuromuscular disorders, psychiatric conditions, and current therapeutic vitamin/mineral supplements. Outcomes will be compared between groups to determine whether supplementation produces greater metabolic or hormonal improvement than placebo.
Who should consider this trial
Good fit: Women aged 19–65 with PCOS diagnosed by Rotterdam criteria who are not pregnant or breastfeeding and do not have major liver, kidney, thyroid, neurological, or psychiatric disorders and are not taking therapeutic vitamin/mineral supplements.
Not a fit: Women who are menopausal, pregnant or breastfeeding, have hypothyroidism, significant liver or kidney disease, seizure or neuromuscular disorders, or who already take therapeutic supplements are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could provide a low-cost, well-tolerated option to improve insulin sensitivity, lipid profiles, and reduce hirsutism in women with PCOS.
How similar studies have performed: Prior small studies of magnesium or L-carnitine alone have reported modest improvements in insulin resistance and lipid measures, but combined supplementation in PCOS is less well studied and remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tehran, Tehran Province
- Tara Momeni — Tehran, Tehran Province, Iran (Recruiting)
Study contacts
- Study coordinator: Behnood Abbasi
- Email: abbasi.b@srbiau.ac.ir
- Phone: +9821 44864929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.