Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-04-12 @ 2:46 AM
Study NCT ID:
NCT02178150
Status:
UNKNOWN
Last Update Posted:
2015-03-10
First Post:
2014-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-08', 'studyFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum insulin level', 'timeFrame': '8 Weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin Resistance', 'timeFrame': '8 weeks'}, {'measure': 'Fasting Blood Sugar', 'timeFrame': '8 weeks'}, {'measure': 'Quantitative insulin sensitivity check index (Quicki)', 'timeFrame': '8 weeks'}, {'measure': 'HOMA-IR', 'timeFrame': '8 weeks'}, {'measure': 'HOMA-B', 'timeFrame': '8 weeks'}, {'measure': 'High Density Lipoprotein', 'timeFrame': '8 weeks'}, {'measure': 'Low Density Lipoprotein', 'timeFrame': '8 weeks'}, {'measure': 'Triglyceride', 'timeFrame': '8 weeks'}, {'measure': 'Total Cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'Androgen', 'timeFrame': '8 weeks'}, {'measure': 'Testosterone', 'timeFrame': '8 weeks'}, {'measure': 'C-Reactive Protein', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnesium', 'Insulin Resistance', 'Lipid profile', 'Sex hormones', 'Inflammatory factors'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '31960275', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having PCOS according to the Rotterdam criteria,\n* Age between 20-45 years,\n* Lack of pregnancy and lactation,\n* Not having certain regime during last 3 months,\n* Non-smoking,\n* Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,\n* Not taking supplements,\n* Being overweight (Kg / m 25 ≤ BMI)\n\nExclusion Criteria:\n\n* Hormone Therapy,\n* Pregnancy and lactation during the study,\n* Severe weight loss (more than 2.5 kg per month) during the study'}, 'identificationModule': {'nctId': 'NCT02178150', 'briefTitle': 'Effect of Magnesium Supplementation on Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.', 'orgStudyIdInfo': {'id': '18201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium Oxide', 'description': 'magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet', 'interventionNames': ['Dietary Supplement: Magnesium Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Magnesium Oxide', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Magnesium Oxide']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Ahmad Esmaeilzadeh, professor', 'role': 'CONTACT', 'email': 'esmaillzadeh@hlth.mui.ac.ir', 'phone': '3117922776', 'phoneExt': '0098'}, {'name': 'Ahmad Esmaeilzadeh, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Isfahan University of Medical Sciences', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'Ahmad Esmaeilzadeh, Professor', 'role': 'CONTACT', 'email': 'esmaillzadeh@hlth.mui.ac.ir', 'phone': '3117922776', 'phoneExt': '0098'}, {'name': 'maryam farsinejadmarj, Bachelor', 'role': 'CONTACT', 'email': 'maryam.farsinejad@yahoo.com', 'phone': '9374760794', 'phoneExt': '0098'}], 'overallOfficials': [{'name': 'Ahmad Esmaeilzadeh, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Leila Azadbakht', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}