Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Magnesium Oxide; Dietary Supplement: Placebo

• Registration Number: NCT02178150
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Last Update Submitted: 2015-03-08
• Last Update Posted: 2015-03-10
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Having PCOS according to the Rotterdam criteria,
• Age between 20-45 years,
• Lack of pregnancy and lactation,
• Not having certain regime during last 3 months,
• Non-smoking,
• Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
• Not taking supplements,
• Being overweight (Kg / m 25 ≤ BMI)

Exclusion Criteria

• Hormone Therapy,
• Pregnancy and lactation during the study,
• Severe weight loss (more than 2.5 kg per month) during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Oxide	Magnesium Oxide	magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet
Placebo	Placebo	Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day

Primary Outcome Measures

Name	Time	Method
Serum insulin level	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance	8 weeks
Fasting Blood Sugar	8 weeks
Quantitative insulin sensitivity check index (Quicki)	8 weeks
HOMA-B	8 weeks
High Density Lipoprotein	8 weeks
Low Density Lipoprotein	8 weeks
Triglyceride	8 weeks
Total Cholesterol	8 weeks
Androgen	8 weeks
Testosterone	8 weeks
C-Reactive Protein	8 weeks
HOMA-IR	8 weeks

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of