Nctid:
NCT00001309
Payload:
{"FullStudy"=>{"Rank"=>492317, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"May 02, 2024"}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M4513", "InterventionBrowseLeafName"=>"Ascorbic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17558", "InterventionBrowseLeafName"=>"Vitamins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T477", "InterventionBrowseLeafName"=>"Vitamin C", "InterventionBrowseLeafAsFound"=>"Physiotherapy", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"T437", "InterventionBrowseLeafName"=>"Ascorbic Acid", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"N/A", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Basic Science", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"23"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 23, 1997", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 21, 2024", "CompletionDateStruct"=>{"CompletionDate"=>"March 4, 2019", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"April 17, 2024", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 18, 2024", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 25, 1999", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Changes in ascorbic acid concentrations", "PrimaryOutcomeTimeFrame"=>"5 years", "PrimaryOutcomeDescription"=>"In this study researchers will attempt to determine how the amount of water consumed affects the level of vitamin C in the blood (specifically the plasma component of the blood)."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Pharmacokinetics", "Biodistribution", "Ascorbic Acid"]}, "ConditionList"=>{"Condition"=>["Healthy Volunteers"]}}, "ReferencesModule"=>{"SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1992-DK-0033.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Pharmacokinetics is the term used for how the body affects a drug once it is taken. Vitamin C, also known as ascorbic acid, is an essential water soluble vitamin. Meaning, the body does not make Vitamin C it must be taken in through the diet. In this study researchers will attempt to determine how the amount of water consumed affects the level of vitamin C in the blood (specifically the plasma component of the blood).\n\nIn this study researchers will take 13 subjects and place them on a Vitamin C restricted diet. Vitamin C levels will be measured twice a week on an outpatient basis until all subjects reach a desired low level of Vitamin C (12-15 micromolar plasma ascorbic acid concentration). Subjects will then be admitted and undergo 24 hour blood and urine collection. Following the collection of samples, subjects will then begin to receive Vitamin C orally (by mouth) and intravenously (injected into the vein). The dosage of Vitamin C will gradually increase from 30 mg-2500 mg divided into two daily doses. Blood and urine samples will be collected each time the dose is increased. The study will take approximately 18 weeks after which the subjects will be discharged in healthy condition.", "DetailedDescription"=>"Vitamin C (ascorbic acid, ascorbate) is an essential water soluble vitamin. Our studies at NIH were the first to demonstrate in healthy men and women how changes in a vitamin concentration in human plasma vary as a direct function of the amount ingested, over a wide range. ln the present study, we plan to achieve a prescorbutic vitamin C plasma concentration of approximately 5-10 micromolar in healthy human volunteers. We will gradually replete these subjects with incremental doses of vitamin C to measure how their plasma, red blood cell, and leukocyte concentrations will change as a function of the dose. We will also determine whether changes in vitamin C concentration result in changes in gene expression and metabolic profiles (metabolomics, lipidomics, proteomics).\n\nOutpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection. At steady state of each of 4 to 5 doses, an apheresis procedure will be performed for collection of platelets and leukocytes. lt is anticipated subjects will be discharged in healthy condition after 20-26 weeks."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"35 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n10 Males - ages 18 - 35 yrs\n10 Females - ages 18 - 35 yrs\n\nNo more than 4 subjects during any period will remain as inpatients on the endocrine/metabolic ward. These subjects will be normal volunteers selected from colleges/universities who will:\n\nSpend within a fall or spring semester (approximately 20-26 weeks) as an inpatient resident on the endocrine-metabolic ward at NIH.\nBe willing to adhere to an ascorbate restricted diet for the duration of the time spent in the study as an inpatient at NlH.\nHave veins adequate for venipunctures and be willing to undergo venipunctures approximately two to three times per week.\nRefrain from ingestion of any medication and cigarette smoking and ethanol.\nBe able to give informed consent.\n\nEXCLUSION CRITERIA:\n\nSubject non-compliance with restricted diet.\nPregnancy as determined by history, physical exam and urine b-HCG.\nHistory of diabetes mellitus, bleeding disorders, kidney stones, glucose-6- phosphate dehydrogenase deficiency, family history of hemochromatosis/iron overload.\nPlatelet count <150,000/ul blood; prothrombin time/partial thromboplastin time (PT/PTT) > 1 second above normal upper limit.\nPositive test for exposure to human immunodeficiency virus.\nPositive tests for hepatitis B surface antigen, core antibody or surface antibody."}, "IdentificationModule"=>{"NCTId"=>"NCT00001309", "BriefTitle"=>"The Body's Affect on Vitamin C", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Pharmacokinetics and Biodistribution of Ascorbic Acid in Healthy Human Subjects", "OrgStudyIdInfo"=>{"OrgStudyId"=>"920033"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"92-DK-0033"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Other", "ArmGroupLabel"=>"Pharmacokinetics and Biodistribution of Ascorbic Acid", "ArmGroupDescription"=>"Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Other: Vitamin C"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Vitamin C", "InterventionType"=>"Other", "InterventionDescription"=>"Outpatient subjects will be encouraged to consume vitamin C in foods. As inpatients, vitamin C deficiency will be induced by placing subjects on a tightly restricted scorbutic diet. Plasma vitamin C will be monitored several times per week. When subjects have achieved a plasma ascorbate concentration of 5-10 micromolar, blood sampling and urine collection over 24 hours will be performed. After platelets and leukocytes are collected, ascorbate repletion will begin. Escalating doses of ascorbate will be administered orally and intravenously for the remainder of their inpatient admission. Total daily doses of 30mg, 60mg, 100mg, 200mg, 400mg, 1000mg and 2500mg will be given in two divided doses. Bioavailability of ascorbate will be determined at each dosage increment. When plasma ascorbate concentration reaches steady state for each dose, subjects will undergo 36 hr plasma sampling and a timed 48 hr urine collection.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Pharmacokinetics and Biodistribution of Ascorbic Acid"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Mark A Levine, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
