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Trial record 11 of 115 for:    Polycystic Ovary Syndrome: Clinical Trials

Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02178150
Recruitment Status : Unknown
Verified June 2014 by Leila Azadbakht, Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 30, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: Magnesium Oxide Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
Study Start Date : June 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet
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 Comparator: Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Serum insulin level [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 8 weeks ]
  2. Fasting Blood Sugar [ Time Frame: 8 weeks ]
  3. Quantitative insulin sensitivity check index (Quicki) [ Time Frame: 8 weeks ]
  4. HOMA-IR [ Time Frame: 8 weeks ]
  5. HOMA-B [ Time Frame: 8 weeks ]
  6. High Density Lipoprotein [ Time Frame: 8 weeks ]
  7. Low Density Lipoprotein [ Time Frame: 8 weeks ]
  8. Triglyceride [ Time Frame: 8 weeks ]
  9. Total Cholesterol [ Time Frame: 8 weeks ]
  10. Androgen [ Time Frame: 8 weeks ]
  11. Testosterone [ Time Frame: 8 weeks ]
  12. C-Reactive Protein [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178150


Contacts
Contact: Ahmad Esmaeilzadeh, Professor 3117922776 ext 0098 esmaillzadeh@hlth.mui.ac.ir
Contact: maryam farsinejadmarj, Bachelor 9374760794 ext 0098 maryam.farsinejad@yahoo.com

Locations
Iran, Islamic Republic of
Isfahan University of Medical Sciences Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Ahmad Esmaeilzadeh, professor    3117922776 ext 0098    esmaillzadeh@hlth.mui.ac.ir   
Principal Investigator: Ahmad Esmaeilzadeh, professor         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: Ahmad Esmaeilzadeh, professor Isfahan University of Medical Sciences

Responsible Party: Leila Azadbakht, Associate Professor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02178150     History of Changes
Other Study ID Numbers: 18201
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: June 2014

Keywords provided by Leila Azadbakht, Isfahan University of Medical Sciences:
Magnesium
Insulin Resistance
Lipid profile
Sex hormones
Inflammatory factors

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hormones
Magnesium Oxide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents