Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178150
• Other study ID #: 18201
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2014
• Last updated: March 8, 2015
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Isfahan University of Medical Sciences
• Contact: Ahmad Esmaeilzadeh, Professor
• Phone: 3117922776
• Email: esmaillzadeh[@]hlth.mui.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Magnesium Oxide
This is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 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 metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements.
• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum insulin level		8 Weeks	Yes
Secondary	Insulin Resistance		8 weeks	Yes
Secondary	Fasting Blood Sugar		8 weeks	Yes
Secondary	Quantitative insulin sensitivity check index (Quicki)		8 weeks	Yes
Secondary	HOMA-IR		8 weeks	Yes
Secondary	HOMA-B		8 weeks	Yes
Secondary	High Density Lipoprotein		8 weeks	Yes
Secondary	Low Density Lipoprotein		8 weeks	Yes
Secondary	Triglyceride		8 weeks	Yes
Secondary	Total Cholesterol		8 weeks	Yes
Secondary	Androgen		8 weeks	Yes
Secondary	Testosterone		8 weeks	Yes
Secondary	C-Reactive Protein		8 weeks	Yes