Effect of Magnesium Supplementation on Polycystic Ovary Syndrome
NCT ID: NCT02178150
Last Updated: 2015-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2014-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet
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
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion 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
* Pregnancy and lactation during the study,
* Severe weight loss (more than 2.5 kg per month) during the study
20 Years
45 Years
FEMALE
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Leila Azadbakht
Associate Professor
Principal Investigators
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Ahmad Esmaeilzadeh, professor
Role: STUDY_CHAIR
Isfahan University of Medical Sciences
Locations
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Isfahan University of Medical Sciences
Isfahan, Isfahan, Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Farsinejad-Marj M, Azadbakht L, Mardanian F, Saneei P, Esmaillzadeh A. Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome. Biol Trace Elem Res. 2020 Aug;196(2):349-358. doi: 10.1007/s12011-019-01923-z. Epub 2020 Jan 20.
Other Identifiers
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18201
Identifier Type: -
Identifier Source: org_study_id
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