Actively Recruiting
Assessment of the Effect of Magnesium and Levocarnitine Co-supplementation on Lipid Profile, Glycemic Control Indicators and Hirsutism in Women With Polycystic Ovarian Syndrome
Led by Behnood Abbasi · Updated on 2025-12-23
84
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder in women of reproductive age that can cause insulin resistance, abnormal cholesterol levels, hormonal imbalances, infertility, and excessive hair growth. This research evaluates the effects of taking magnesium and L-carnitine supplements together on blood sugar control, cholesterol levels, and hirsutism in women with PCOS. The trial is randomized, triple-blind, and placebo-controlled, involving 84 women aged 19 to 65 diagnosed by the Rotterdam criteria. Participants are assigned to one of three groups for 12 weeks: one group takes magnesium supplements (500 mg daily split into two doses) plus a placebo for L-carnitine; another takes L-carnitine supplements (1000 mg daily) plus magnesium; and the third group receives placebo capsules matching both supplements. The study collects data on physical activity, diet, body measurements, blood pressure, and blood samples for glucose, insulin, cholesterol, and insulin resistance. Hirsutism is assessed using a standardized scoring method. Throughout the study, participants' weight, height, waist circumference, and blood pressure are measured. Blood tests are done after fasting to measure fasting blood sugar, lipid profile, hemoglobin A1c, insulin levels, and insulin resistance using the HOMA-IR calculation. Hirsutism scores are recorded before and after the intervention. Adherence is monitored by counting remaining capsules, excluding those who consume less than 90%. The study aims to track changes in these measures from the start to 12 weeks later.
CONDITIONS
Brief Title
Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 65 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Female gender.
You will not qualify if you...
- Hypothyroidism.
- Menopause.
- Pregnancy or breastfeeding.
- Renal (kidney) dysfunction.
- Use of therapeutic vitamin or mineral supplements.
- Liver diseases such as grade 3 fatty liver, hepatitis, or cirrhosis.
- Psychiatric disorders including bipolar disorder.
- Neuromuscular diseases such as myasthenia gravis, Parkinson's disease, multiple sclerosis, epilepsy, or muscular dystrophy.
- History of seizures.
- Becoming pregnant during the study or failing to comply with more than 20% of the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive magnesium and/or Levocarnitine supplements or placebo daily for 12 weeks to evaluate effects on metabolic and hormonal outcomes.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Tara Momeni
Tehran, Tehran Province, Iran
Actively Recruiting
Research Team
B
Behnood Abbasi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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