Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
Polycystic Ovary Syndrome, Hyperandrogenism, Insulin Resistance, Dyslipidemia, Hirsutism
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.
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.
Interventions
DIETARY_SUPPLEMENTMagnesium 500 mg
Participants will receive magnesium supplement 500 mg daily in two divided doses of 250 mg each for 12 weeks. Magnesium Placebo
DIETARY_SUPPLEMENTLevocarnitine 1000 mg
Participants will receive Levocarnitine supplement 1000 mg daily for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Participants will receive placebo capsules matching magnesium and Levocarnitine for 12 weeks.
DIETARY_SUPPLEMENTPlacebo Levocarnitine
Participants will receive placebo matching Levocarnitine 1000 mg daily for 12 weeks.
Sponsors
Behnood Abbasi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of FBS | Baseline and 12 weeks after | Fasting blood glucose concentration (mg/dl) (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of HbA1c | Baseline and 12 weeks after | — |
| Change from baseline of HOMA-IR | Baseline and 12 weeks after | Calculated as \[fasting glucose (mg/dL) × fasting insulin (µIU/mL) / 405\] |
| Change from baseline of total cholesterol | Baseline and 12 weeks after | Serum TC (total cholesterol) concentration (mg/dl) |
| Change from Baseline of serum insulin | Baseline and 12 weeks after | Serum insulin (µIU/mL) |
| Change from baseline of low density lipoprotein cholesterol (LDL-Cholesterol) | Baseline and 12 weeks after | Serum LDL concentration (mg/dl) |
| Change from baseline of high density lipoprotein cholesterol (HDL-Cholesterol) | Baseline and 12 weeks after | Serum HDL concentration (mg/dl) |
| Change from baseline of Triglyceride | Baseline and 12 weeks after | Serum TG (triacylglycerol) concentration (mg/dl) |
Countries
Iran
Contacts
Primary ContactBehnood Abbasi
Outcome results
None listed