Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-01 @ 12:31 PM
Study NCT ID:
NCT00833092
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnesium Nutrition and Sleep Behavior in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D008274', 'term': 'Magnesium'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'forrest.nielsen@ars.usda.gov', 'phone': '701-790-8455', 'title': 'Forrest H Nielsen, PhD', 'organization': 'USDA Grand Forks Human Nutrition ResearchCenter'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sugar Pill', 'description': 'zero magnesium supplementation', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Magnesium', 'description': '300 milligrams of magnesium daily', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugar Pill', 'description': 'zero magnesium supplementation'}, {'id': 'OG001', 'title': 'Magnesium', 'description': '300 milligrams of magnesium daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '6.96', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 weeks', 'description': 'Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugar Pill', 'description': 'zero magnesium supplementation'}, {'id': 'FG001', 'title': 'Magnesium', 'description': '300 milligrams of magnesium daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Diarrhea', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'constipation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.', 'preAssignmentDetails': '425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugar Pill', 'description': 'zero magnesium supplementation'}, {'id': 'BG001', 'title': 'Magnesium', 'description': '300 milligrams of magnesium daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-06', 'studyFirstSubmitDate': '2009-01-27', 'resultsFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2009-01-28', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-07', 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Pittsburgh Sleep Quality Index', 'timeFrame': '9 weeks', 'description': 'Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnesium', 'Nutritional Requirements', 'Sleep'], 'conditions': ['Nutritional Deficiency', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '7481413', 'type': 'BACKGROUND', 'citation': 'Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.'}, {'pmid': '17023712', 'type': 'BACKGROUND', 'citation': 'Hunt CD, Johnson LK. Magnesium requirements: new estimations for men and women by cross-sectional statistical analyses of metabolic magnesium balance data. Am J Clin Nutr. 2006 Oct;84(4):843-52. doi: 10.1093/ajcn/84.4.843.'}, {'pmid': '12949381', 'type': 'BACKGROUND', 'citation': 'Ford ES, Mokdad AH. Dietary magnesium intake in a national sample of US adults. J Nutr. 2003 Sep;133(9):2879-82. doi: 10.1093/jn/133.9.2879.'}]}, 'descriptionModule': {'briefSummary': 'Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.', 'detailedDescription': 'Insomnia affects approximately one-third of older Americans. More than half of all people aged 65 and older experience sleep problems. The prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. One of those factors may be a deficient magnesium status. There is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (GABA) system. Because magnesium is a natural N-methyl-D-aspartate (NMDA)antagonist and GABA agonist, magnesium apparently plays a key role in the regulation of sleep. Such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '51 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have sleep complaints\n* Score greater than 5 on Pittsburgh Global Sleep Quality Index\n\nExclusion Criteria:\n\n* taking medications that affect sleep\n* taking 100 milligrams or more of magnesium\n* body mass index of 40 or higher\n* abnormal breathing conditions'}, 'identificationModule': {'nctId': 'NCT00833092', 'briefTitle': 'Magnesium Nutrition and Sleep Behavior in Older Adults', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Magnesium Nutrition and Sleep Behavior in Older Adults', 'orgStudyIdInfo': {'id': 'GFHNRC014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Sugar Pill', 'interventionNames': ['Dietary Supplement: Sugar Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'magnesium', 'description': '300 milligrams of magnesium daily', 'interventionNames': ['Dietary Supplement: magnesium']}], 'interventions': [{'name': 'Sugar Pill', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sugar pill supplementation for 9 weeks', 'armGroupLabels': ['Sugar pill']}, {'name': 'magnesium', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 milligrams daily for 8 weeks', 'armGroupLabels': ['magnesium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58202', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Forrest H Nielsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}