{
  "FullStudy":{
    "Rank":218258,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510665",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Magnesium123"
          },
          "Organization":{
            "OrgFullName":"University of California, Los Angeles",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals",
          "OfficialTitle":"Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 23, 2011",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 12, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 14, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Simin Liu, Dr.",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"University of California, Los Angeles"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of California, Los Angeles",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a prospective, randomized, placebo controlled study with three parallel arms examining the effects of magnesium supplementation in the second trimester of pregnancy.\n\nRecent research has shown that supplemental magnesium can have beneficial effects, especially in overweight individuals. Not only do many people have a magnesium deficient diet, there is also evidence that magnesium can improve blood sugar levels. Due to the growing concern of obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.\n\nIn this study, 60 overweight and obese pregnant patients in their first trimester will be enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg elemental Magnesium), group B will receive dietary counseling about following a magnesium rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine specimens will be collected at three time points during the pregnancy to analyze changes in levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and maternal complications of pregnancy will be noted, including maternal weight gain. At delivery, patients will have a placental cord blood specimen and placental biopsy collected for gene expression patterns and further analysis."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Gestational Diabetes",
              "Obesity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Weight gain in pregnancy",
              "Metabolic and Inflammatory markers"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"28",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Magnesium Supplement",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Magnesium citrate dietary supplement (300 mg elemental Magnesium daily dose) given week 13 to week 28 (two pills daily)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Magnesium citrate"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Identical appearing pill with inactive ingredients given week 13 to week 28 (two pills daily)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Diet",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Nutritionist counseling session and advice on following a magnesium rich diet from week 13 to week 28",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Dietary modification"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Magnesium citrate",
                "InterventionDescription":"Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Magnesium Supplement"
                  ]
                }
              },{
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Placebo",
                "InterventionDescription":"Identical appearing placebo with inactive ingredients, two pills once daily.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Dietary modification",
                "InterventionDescription":"Nutritionist counseling session and advice on following a magnesium rich diet",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diet"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in maternal biomarkers during pregnancy up to 28 weeks",
                "PrimaryOutcomeDescription":"Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to second trimester values, which will be up to 28 weeks.",
                "PrimaryOutcomeTimeFrame":"up to 28 weeks"
              },{
                "PrimaryOutcomeMeasure":"Neonatal birth weight/height",
                "PrimaryOutcomeDescription":"This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Neonatal weight and height at birth will be assessed.",
                "PrimaryOutcomeTimeFrame":"Up to 10 months"
              },{
                "PrimaryOutcomeMeasure":"Change in maternal biomarkers in pregnancy in the third trimester",
                "PrimaryOutcomeDescription":"Blood and urine markers of inflammatory and metabolic markers will be assessed during the pregnancy,comparing baseline values to third trimester values, which will be up to 36 weeks.",
                "PrimaryOutcomeTimeFrame":"Up to 36 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Neonatal outcomes",
                "SecondaryOutcomeDescription":"This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. At delivery, neonatal characteristics will be assessed:\n\nMacrosomia, preterm birth, head circumference, and apgar score.",
                "SecondaryOutcomeTimeFrame":"Up to 10 months"
              },{
                "SecondaryOutcomeMeasure":"Neonatal tertiary outcomes",
                "SecondaryOutcomeDescription":"This measure will be assessed at neonatal delivery, which will occur at a maximum of up to 10 months from randomization. Cord blood and placenta will be collected at delivery, and we will examine endothelial progenitor cell presence in cord blood, PON expression in cord blood, and DNA expression from the placental tissue.",
                "SecondaryOutcomeTimeFrame":"Up to 10 months"
              },{
                "SecondaryOutcomeMeasure":"Pregnancy complications",
                "SecondaryOutcomeDescription":"From date of randomization until the date of delivery of the neonate, up to a maximum of 10 months, pregnancy complications such as development of gestational diabetes, hypertension, proteinuria, shoulder dystocia, cesarean section, as well as amount of weight gain will be assessed from the chart.",
                "SecondaryOutcomeTimeFrame":"Up to 10 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBetween 18 and 40 years of age\nPregnant in the first trimester\nAble to give informed consent\nPlanning to deliver at UCLA\nBMI greater than or equal to 25\n\nExclusion Criteria:\n\nOn insulin therapy or other oral hypoglycemic agents\nMultiple gestation\nBaseline HgbA1C > 6.5%\nPrior history of clinically diagnosed T2D\nMultiple dietary restrictions/food allergies\nHeart, renal, or liver failure\nClinical history of psychiatric illness or substance abuse\nOut of town travel planned at study visits",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Simin Liu, MD, ScD, MS, MPH",
                "OverallOfficialAffiliation":"University of California, Los Angeles",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"200 Medical Plaza UCLA Ob/Gyn Clinic",
                "LocationCity":"Westwood",
                "LocationState":"California",
                "LocationZip":"90095",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"West Medical UCLA Ob/Gyn Clinic",
                "LocationCity":"Westwood",
                "LocationState":"California",
                "LocationZip":"90095",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000110422",
                "InterventionMeshTerm":"Magnesium citrate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002400",
                "InterventionAncestorTerm":"Cathartics"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M19904",
                "InterventionBrowseLeafName":"Citric Acid",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M1837",
                "InterventionBrowseLeafName":"Sodium Citrate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M216347",
                "InterventionBrowseLeafName":"Magnesium citrate",
                "InterventionBrowseLeafAsFound":"Magnesium citrate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M26251",
                "InterventionBrowseLeafName":"Laxatives",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4234",
                "InterventionBrowseLeafName":"Cathartics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T382",
                "InterventionBrowseLeafName":"Citrate",
                "InterventionBrowseLeafAsFound":"Citrate",
                "InterventionBrowseLeafRelevance":"high"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnCoag",
                "InterventionBrowseBranchName":"Anticoagulants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Ot",
                "InterventionBrowseBranchName":"Other Dietary Supplements"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000016640",
                "ConditionMeshTerm":"Diabetes, Gestational"
              },{
                "ConditionMeshId":"D000050177",
                "ConditionMeshTerm":"Overweight"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001835",
                "ConditionAncestorTerm":"Body Weight"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000011248",
                "ConditionAncestorTerm":"Pregnancy Complications"
              },{
                "ConditionAncestorId":"D000003920",
                "ConditionAncestorTerm":"Diabetes Mellitus"
              },{
                "ConditionAncestorId":"D000044882",
                "ConditionAncestorTerm":"Glucose Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
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            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafAsFound":"Overweight",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16684",
                "ConditionBrowseLeafName":"Weight Gain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M17595",
                "ConditionBrowseLeafName":"Diabetes, Gestational",
                "ConditionBrowseLeafAsFound":"Gestational Diabetes",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12710",
                "ConditionBrowseLeafName":"Pregnancy Complications",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              }
            ]
          }
        }
      }
    }
  }
}