Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

NCT ID: NCT02178150

Last Updated: 2015-03-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Magnesium Oxide

magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet

Group Type ACTIVE_COMPARATOR

Magnesium Oxide

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Ahmad Esmaeilzadeh, Professor

Role: CONTACT

3117922776 ext. 0098

maryam farsinejadmarj, Bachelor

Role: CONTACT

9374760794 ext. 0098

Facility Contacts

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Ahmad Esmaeilzadeh, professor

Role: primary

3117922776 ext. 0098

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.

Reference Type DERIVED
PMID: 31960275 (View on PubMed)

Other Identifiers

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18201

Identifier Type: -

Identifier Source: org_study_id

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