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.
