Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 6:52 PM
Study NCT ID:
NCT01405794
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
Sponsor:
Organization:
Raw JSON
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32ppm)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change Potassium Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Chloride Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '105.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '105.5', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 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32ppm)', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Alkaline Phosphatase Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '89.0', 'spread': '60.4', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '48.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Aspartate Aminotransferase Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 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32ppm)', 'unitOfMeasure': 'k/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Granulocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Lymphocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Monocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Basophils Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Eosinophils Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cytochrome P450 Assay on Dextromethorphan in Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '5.53', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cytochrome P450 Assay on Losartan in Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cytochrome P450 Assay on Caffeine in Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '3.34', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cytochrome P450 Assay on Omeprazole in Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '2311', 'spread': '494', 'groupId': 'OG000'}, {'value': '1912', 'spread': '334', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cytochrome P450 Assay on Midazolam in Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '9.62', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '9.18', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Change in Systolic Blood Pressure Silver Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail', 'unitOfMeasure': 'mmhg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Change in Diastolic Blood Pressure Silver Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail', 'unitOfMeasure': 'mmhg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Change in Heart Rate in Silver Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': '32ppm Oral Silver'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail', 'unitOfMeasure': 'beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).'}], 'periods': [{'title': 'First Dose Placebo (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '72 hr Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Second Dose 32ppm Oral Silver (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2011-07-19', 'resultsFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-24', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Sodium Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change Potassium Blood Levels', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change in Chloride Blood Levels', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change in Carbon Dioxide Blood Levels', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Urea Nitrogen Blood Levels', 'timeFrame': '14 days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Creatinine Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Glucose Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Alkaline Phosphatase Blood Level', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Aspartate Aminotransferase Blood Level', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Alanine Aminotransferase Blood Level', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change in Total Protein Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Total Bilirubin Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Albumin Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Calcium Blood Level', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In White Blood Count Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Red Blood Count Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Hemoglobin Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Hematocrit Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Mean Corpuscular Volume Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Mean Corpuscular Hemoglobin Concentration Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Platelet Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Granulocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Lymphocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Monocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Basophils Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Change In Eosinophils Blood Levels', 'timeFrame': '14 Days', 'description': 'Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)'}, {'measure': 'Cytochrome P450 Assay on Dextromethorphan in Participants', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}, {'measure': 'Cytochrome P450 Assay on Losartan in Participants', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}, {'measure': 'Cytochrome P450 Assay on Caffeine in Participants', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}, {'measure': 'Cytochrome P450 Assay on Omeprazole in Participants', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}, {'measure': 'Cytochrome P450 Assay on Midazolam in Participants', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}], 'secondaryOutcomes': [{'measure': 'Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver', 'timeFrame': '14 Days', 'description': 'Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.'}, {'measure': 'Total Change in Systolic Blood Pressure Silver Participants', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail'}, {'measure': 'Total Change in Diastolic Blood Pressure Silver Participants', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail'}, {'measure': 'Total Change in Heart Rate in Silver Participants', 'timeFrame': 'Baseline and 14 Days', 'description': 'Assessment only completed on the 32ppm Oral Silver part of the trail'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23811290', 'type': 'DERIVED', 'citation': 'Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old without debilitating chronic disease or history of cardiovascular event.\n\nExclusion Criteria:\n\n* Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;\n* Any female who is nursing;\n* History of heavy metal allergy;\n* History of asthma or Chronic Obstructive Pulmonary Disease;\n* History of renal impairment;\n* Symptoms of active upper respiratory disease at time of consent;\n* Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;\n* Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.'}, 'identificationModule': {'nctId': 'NCT01405794', 'briefTitle': 'In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'orgStudyIdInfo': {'id': '50310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '32ppm Oral Silver', 'description': '14 Days Active Silver Solution', 'interventionNames': ['Drug: 32ppm Silver Particle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile Water', 'description': 'No Silver Nanoparticles', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '32ppm Silver Particle', 'type': 'DRUG', 'description': 'Oral silver dose of 32ppm', 'armGroupLabels': ['32ppm Oral Silver']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile Water No Silver', 'armGroupLabels': ['Sterile Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112-5820', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Mark Munger, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'mark munger', 'investigatorAffiliation': 'University of Utah'}}}}